PRODUCT ADVISORIES DEEP BRAIN STIMULATION

Product Advisories

Medtronic is committed to providing you with the highest quality products and services and ongoing support.

As part of our commitment, we have created this forum to house important information learned from ongoing use and experience with our products. We believe the content of these product advisories will further patient safety and improve outcomes.

For further information, please contact us

2017

URGENT: MEDICAL DEVICE CORRECTION— MARCH 2017

DEEP BRAIN STIMULATION THERAPY: IMPORTANT INFORMATION REGARDING THE DEEP BRAIN STIMULATION (DBS) LEAD DEPTH STOP

Models Affected: Models 3387/3387S, 3389/3389S, and 3391/3391S DBS Lead Kits

Description:

This notification provides you important safety information regarding the use of the depth stop accessory provided in all Medtronic Deep Brain Stimulation (DBS) lead kits. The Medtronic DBS depth stop, otherwise referred to as the lead holder, is used to establish the implant depth. The depth stop interfaces with parts of the stereotactic system used during surgery to control placement of the DBS lead tip to the target location. Medtronic has received complaints from physicians reporting that the DBS depth stop did not adequately secure to the lead. This letter provides information regarding this product performance issue, potential risk to patients, and actions to take regarding use of the Medtronic depth stop.

If you do not use the Medtronic depth stop (for example, if you only use the FHC, Alpha Omega, or Nexdrive depth stop), you are not affected and no actions are needed.

Read on for detailed information related to this communication.

2016

URGENT: MEDICAL DEVICE CORRECTION – SEPTEMBER 2016

DEEP BRAIN STIMULATION THERAPY: IMPORTANT INFORMATION REGARDING THE MODEL 37751 RECHARGER

Models Affected: Model 37751 Recharger, which is included in Model 37651 Charging System for DBS

Description:

This notification communicates important information regarding the issue of unresponsive and beeping Model 37751 Rechargers, and provides information on how to prevent occurrence of this issue and restore functionality of the Recharger if the issue occurs. Medtronic has identified an increased number of complaints from customers involving reports of Rechargers that that are in an unresponsive error state, where the Recharger is non-functional with a blank display screen and is beeping every 5 seconds. This Recharger is used by DBS patients who are implanted with a Medtronic Activa® RC (Model 37612) implantable neurostimulator.

Read on for detailed information related to this communication.

Urgent Medical Device Safety Notification – June 2016

Deep Brain Stimulation Therapy: Important Information Regarding Adaptor Handling During Implant Procedure

Models Affected: DBS Pocket Adaptor Models 64001 and 64002

Description:

This notification communicates recent results from returned product analysis of Medtronic Neuromodulation Deep Brain Stimulation (DBS) system pocket adaptors with reports of high impedances, and reinforces device labeling specific to the handling of pocket adaptors and system integrity checking during implant procedures. This applies to pocket adaptor Models 64001 and 64002 which can be used with the following implantable Neurostimulators: Activa® PC (Model 37601) and Activa® RC (Model 37612).

Read on for detailed information related to this communication.

Urgent Medical Device Safety Notification – May 2016

Deep Brain Stimulation Therapy: Reported Events Related to Loss of Coordination

Models Affected: 37612, 37601, 37602, 7428, 7426

Description:

This physician notification provides important information on adverse events for DBS Therapy identified through Medtronic’s ongoing surveillance of reported events and published literature. One report has been identified of an inability to swim following DBS implantation and initiation of DBS therapy for Parkinson’s disease in a patient who was an experienced swimmer. Physicians and patients should be aware that loss of coordination is identified in labeling as a potential side effect of DBS therapy, and may result in, for example, the inability to swim. Patients should be made aware that participating in any activities requiring coordination that they were previously able to perform may place them in an unsafe situation; therefore these activities should be performed under supervision after DBS therapy is first turned on and after programming changes until any effects of their DBS therapy on coordination are understood.

Read on for detailed information related to this communication.

Urgent Medical Device Safety Notification – May 2016

Deep Brain Stimulation Therapy: Reported Events Related to DBS Tunneling Procedure

Models Affected: 7483, 37086

Description:

This physician notification provides important information on adverse events for DBS Therapy identified through Medtronic’s ongoing surveillance of reported events and published literature. The following serious events or injuries are associated with the DBS implant and tunneling the extension from the lead to the INS:

Read on for detailed information related to this communication.

• Cases of spinal accessory nerve injury
• Severe bleeding or vascular injury
• An extension inadvertently implanted through the ribs and later found to be close to the heart requiring revision
• Tunneling too superficially resulting in an extension that exited and then re-entered the neck which wasn’t discovered until the surgical drape was removed

2015

Medical Device Safety Notification – April 2015

DBS Extension Handling During Implant Procedure

Description:

This notification reinforces device labeling specific to the handling of extensions and system integrity checking during implant procedures. This applies to extension Models 37085 and 37086, which can be used with the following implantable Neurostimulators: Activa® PC (Model 37601), Activa® RC (Model 37612), and the Activa® SC (Model 37603).

Read on for detailed information related to this communication.

2014

Medical Device Correction – February 2014

Impact of Cycling Feature on Longevity and Recharge Interval

Description:

This notification is associated with corrections to labeling related to the cycling feature in some neurostimulation devices used for deep brain stimulation and spinal cord stimulation.

Read on for detailed information related to this communication.

2013

Urgent: Medical Device Correction – September 2013

Loss of Stimulation and Over Stimulation

Description:

This notification is associated with neurostimulation devices used for both deep brain stimulation and spinal cord stimulation. It provides information regarding the potential for loss of stimulation and the potential for over stimulation. Read on for detailed information.

Read on for detailed information related to this communication.

2007

Recall: Kinetra and Soletra Neurostimulators - October 2007

Important Patient Management Information

Separation of internal connections (lifted wirebonds) between the electronic circuit and battery may lead to sudden cessation of the intervention.

Serial Number Look-up for Kinetra and Soletra

Search for a Serial Number
This Web-based tool can be used to identify whether a specific Kinetra or Soletra neurostimulator serial number is included in the lifted wirebonds device recall dated October 2007.

A problem with a subset of Model 7428 Kinetra® and Model 7426 Soletra® implantable neurostimulators where separation of internal connections (lifted wirebonds) between the electronic circuit and battery may lead to sudden cessation of therapy.

We are aware of 2 failures which led to adverse events where hospitalization was required because return of symptoms was severe. Modification in drug therapy was also required to control symptoms until a replacement device could be implanted. No permanent injury occurred. This letter also provides patient management recommendations for this issue.

In March 2006, Medtronic identified 24 implanted Kinetra devices in the United States and Europe believed to be at risk for this problem, which prompted distribution of customer letters to affected physicians. At that time, Medtronic estimated that up to two of those 24 implanted Kinetra devices may fail due to this problem.

Since that time, 8 additional returned devices were confirmed to have failed due to this problem (6 of which were outside the identified population of 24 implanted devices).

As a result of our on-going monitoring and analysis of this problem, Medtronic is expanding the March 2006 customer communication to include all Kinetra and Soletra devices with electronic circuits that were cleaned with a particular cleaning solvent during manufacturing in several specific time periods.

Sudden cessation of therapy due to any cause (for example, normal or premature battery depletion, component failure) can result in the immediate return of symptoms. Symptoms may be worse due to rebound effect or the possible progression of the disease since initiating Deep Brain Stimulation (DBS) therapy.

• Symptoms specific to dystonia patients may include severe and painful muscle spasms; and for generalized dystonia patients, dystonic crisis.
• Symptoms specific to Parkinson's disease (PD) patients may include severe tremor, rigidity, bradykinesia, and akinetic crisis eventually resulting in decreased mobility.
• Symptoms specific to Essential Tremor patients may include a sudden return of tremor.

These symptoms may not be immediately responsive to pharmacotherapy. This anomaly will leave the device in a non-functional (no telemetry, no output) or Power-On-Reset (POR) state. These states can be intermittent or permanent. The patient cannot rely on the patient programmer to identify this anomaly.

A device can be confirmed to be in the POR state through interrogation of the device with the physician programmer. A device in the POR state will have its parameters reset to the factory default settings with no stimulation output and its serial number will be unavailable.

While it may be possible to successfully reprogram an affected device that is in the POR state, the device may return to the POR state due to the intermittency of this anomaly. Therefore, this anomaly cannot be corrected permanently by reprogramming the device.

Affected Devices

The specific model and serial numbers of affected devices you are following or have implanted are attached to this letter. A serial number look-up application is also available on our website at KinetraSoletra.medtronic.com to confirm affected device serial numbers.

• For Kinetra, there are approximately 1200 devices worldwide that are affected by this communication, with approximately 120 active implants in the United States. To date, a total of approximately 22,000 Kinetra devices have been implanted worldwide.
• For Soletra, there are approximately 1860 devices worldwide that are affected by this communication, with approximately 1240 active implants in the United States. To date, a total of approximately 50,000 Soletra devices have been implanted worldwide.

Root Cause

In the affected devices, separation of internal connections has been observed between the electronic circuit and battery. Electronic circuits used in this subset of affected devices were cleaned with a particular cleaning solvent during manufacturing in several specific time periods that could reduce the strength of the internal connections over time.

A small number of devices manufactured outside these time periods have exhibited this same failure mechanism, and we attribute these failures to a base level of random failures not associated with any identifiable root cause.

Probability of Occurrence

As part of our ongoing returned product analysis, Medtronic has calculated the following data with regard to this failure mechanism.

There is no proactive testing that can predict which devices may fail in the future. The probability of device failure increases with implant duration. For devices from the affected populations that are still implanted and active, we estimate the probability of failure to be between 1.38% (confirmed Kinetra experience) and 2.52% (Weibull prediction model) after 5 years of implant duration.

The total number of additional device failures is estimated to be as many as 31 Kinetra devices and 47 Soletra devices. These estimates include a diverse patient population and variability in implant locations.

Recommendations

We realize that each of your patients is unique, and we support your clinical judgment in caring for them. To assist physicians in their patient care, Medtronic convened a medical advisory board composed of leading United States and European neurologists and neurosurgeons that provided support in developing the following recommendations:

• Consider the potential for this anomaly if your patient presents with a device in a nonfunctional (no telemetry, no output) or POR state
• Consider informing your patients of this risk and advise them to seek attention immediately if they experience a return of pre-implant or more advanced symptoms
• Determine whether prophylactic device replacement is warranted based upon consultation with your patient, including review of the patient's medical history

The following considerations may be helpful for your decision making:

• The length of time the device has been implanted
• The patient's current lifestyle (for example, participating in extreme sports, extensive traveling, operating machinery)
• For PD patients, the potential utility of rescue pharmacological treatment
• The risk of recurrent or worsening symptoms, particularly for generalized dystonia patients
• The relative risks of abrupt cessation of stimulation versus the risk of a device replacement surgical procedure (for example, risk of infection and consequent delay of reinitiating DBS therapy)

Report any malfunction, removal and replacement to Medtronic using the medical device reporting system. Return explanted devices to Medtronic for analysis.

Medtronic is communicating this information to the appropriate regulatory agencies.

For Assistance

Contact your Medtronic representative.