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.
- April 2019 Important Information Regarding ENS Charge Density Warning
- March 2017 Important Information regarding the Deep Brain Stimulation (DBS) Lead Depth Stop
- September 2016 Important Information regarding the Model 37751 Recharger
- June 2016 Important Information Regarding Adaptor Handling During Implant Procedure
- May 2016 Reported Events Related to Loss of Coordination
- May 2016 Reported Events Related to DBS Tunneling Procedure
- April 2015 DBS Extension Handling During Implant Procedure
2019
URGENT: MEDICAL DEVICE CORRECTION – APRIL 2019
DEEP BRAIN STIMULATION THERAPY: IMPORTANT INFORMATION REGARDING ENS CHARGE DENSITY WARNING
Models Affected: DBS Clinician Programmers using the A610 application
Description:
This notification provides important information regarding an issue wherein the charge density warning on the A610 software application does not appear at the expected time during test stimulation. The A610 software includes a Charge Density Warning to alert clinicians during the test stimulation process of settings that may possibly damage nervous tissue. Medtronic has identified during internal testing that under specific system configurations, the charge density warning will not display when expected; specifically, when the External Neurostimulator (ENS) is used during test stimulation with a twistlock cable and neurostimulation lead model 3387 or 3389. In this configuration, the charge density warning on the A610 application will first appear at 60 mC/cm2/phase vs the expected 30mC/cm2/phase.
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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.
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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.
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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).
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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.
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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:
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- 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).
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