Unexplained Syncope

Unexplained syncope

Diagnose syncope with the power of insertable cardiac monitoring (ICM). Turn data into the right clinical decision.

To view the indications, safety, and warnings, scroll down or click on one of the links below to jump you down the page to that product.

LINQ II™ insertable cardiac monitor
Reveal LINQ™ insertable cardiac monitor
AccuRhythm™ AI algorithms

LINQ II™ ICM ISW

Brief statement for LINQ II™ insertable cardiac monitor system (ICM) and accessories

Indications

The LINQ II™ ICM is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least 2 years old, in the following cases:

patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia

Contraindications

There are no known contraindications for the insertion of the LINQ II™ ICM or its accessories. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.

Warnings and precautions

Patients with the LINQ II™ ICM should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound and radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing as described in the Medical Procedure and EMI Warnings, Precautions, and Guidance Manual. MRI scans should be performed only in a specified MR environment under specified conditions as described in the LINQ II™ MRI technical manual.

Accessories available for use with LINQ II™ ICM may experience connectivity or performance issues.  See product manuals for details and troubleshooting instructions.

Potential adverse events or potential complications

Potential adverse events from the LINQ II™ ICM include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.

There are no known adverse events associated with the use of any LINQ II™ ICM accessory.

See the device manuals for detailed information regarding the implant procedure, indications / intended use, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at (800) 328-2518 (Technical Services) or (800) 551-5544 (Patient Services).

Caution: Federal law (United States) restricts prescription devices to sale by or on the order of a physician.

Brief statement for AccuRhythm™ AI ECG classification system

Intended use

The intended use of the system is to reduce false positive cardiac arrhythmia episodes.

Contraindications

There are no known contraindications for AccuRhythm™ AI Models ZA400, ZA410, or ZA420.

Precautions

The AccuRhythm™ AI ECG classification system may incorrectly adjudicate a true positive episode as an AI false episode, causing that episode to be suppressed in the remote monitoring system.

See the device manual for detailed information regarding the intended use, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Medtronic Technical Services at (800) 328-2518.

Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician.

MAJ_83662

Reveal LINQ™ ICM ISW

Brief statement for Reveal LINQ™ insertable cardiac monitor (ICM) system and accessories

Indications

The Reveal LINQ™ insertable cardiac monitor (ICM) is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:

patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
patients who experience transient symptoms such as dizziness, palpitation, syncope and chest pain, that may suggest a cardiac arrhythmia.

The device has not been tested specifically for pediatric use.

Contraindications

There are no known contraindications for the implant of the Reveal LINQ™ ICM or its accessories. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated.

Warnings and precautions

Patients with the Reveal LINQ™ ICM should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound and radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing as described in the Medical procedure and EMI precautions manual. MRI scans should be performed only in a specified MR environment under specified conditions as described in the Reveal LINQ™ MRI technical manual.

Accessories available for use with Reveal LINQ™ ICM may experience connectivity or performance issues. See product manuals for details and troubleshooting instructions.

Potential adverse events or potential complications

Potential complications of the Reveal LINQ device include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.

There are no known adverse events associated with the use of any Reveal LINQ™ ICM accessory.

See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at (800) 328-2518 (Technical Services) or (800) 551-5544 (Patient Services).

Caution: Federal law (United States) restricts prescription devices to sale by or on the order of a physician.

AccuRhythm™ AI ECG classification system brief statement

Intended use

The intended use of the system is to reduce false positive cardiac arrhythmia episodes.

Contraindications

There are no known contraindications for AccuRhythm™ AI Models ZA400, ZA410, or ZA420.

Precautions

The AccuRhythm™ AI ECG classification system may incorrectly adjudicate a true positive episode as an AI false episode, causing that episode to be suppressed in the remote monitoring system.

See the device manual for detailed information regarding the intended use, contraindications, warnings, precautions, and potential complications / adverse events. For further information, call Medtronic Technical Services at (800) 328-2518.

Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician.

MAJ_83854

Improving syncope pathways matters.

Patients who present with a transient loss of consciousness (TLOC) see an average of three specialists^1,2and experience an average of 13 tests prior to receiving an ICM.²

22%

will experience a recurrence at two years.³

42.1%

remain undiagnosed after hospital admission.⁴

Download syncope planning guide (open in new window)

Guidelines recommend early use of ICM in unexplained syncope.^†,5,6

Short-term monitoring prior to ICM is associated with significant delay to definitive diagnosis and arrhythmia treatment.^‡,7

74%

of syncope diagnoses would have been missed with 30-day cardiac monitoring.^§

Long-term, continuous monitoring with ICM results in:

Faster time to diagnosis⁸

Cost-savings due to reduction in downstream testing and hospitalization^9–12

Ruling in or ruling out arrhythmogenic syncope^2,13

Fewer recurrences and less trauma^8,10,14–16

Positive impact on survival: ICM patients lived 1.2 years longer than matched non-ICM cohort.^◊,17

When to consider ICM for unexplained syncope, per ESC and ACC/AHA/HRS guidelines:

Syncope of suspected arrhythmic etiology⁶
If initial noninvasive evaluation is non-diagnostic⁶
Inherited arrhythmias with syncope symptoms (Brugada, etc.), including pediatric patients^¶,5,18
Suspected or certain reflex syncope with frequent or severe episodes^5,18
Patients with recurrent, unexplained syncope with systolic impairment but without current indication for ICD⁵

Consider ICM for patients whose syncope symptoms may be misdiagnosed:

Patients in whom epilepsy was suspected but treatment proved ineffective^5,18
Unexplained falls⁵

Learn more about the guidelines (open in new window)

All ICMs are not created equal. Can you afford to miss an episode?

Discover the most accurate ICMs on the market.^19–31

When you need answers, trust the proven LINQ™ family of ICMs to deliver the data you need to make the right diagnosis for your patients.³²

Detection algorithms

Maintain high detection sensitivity while reducing false episode review burden.³³

Proven technology

1,000+ published clinical articles and abstracts³²

Small, discrete implant³⁴

One-third the size of a AAA battery (1.2 cc)

Fast, safe procedure

< 5 min insertion time^35,36

Available for pediatric syncope patients^¶

LINQ II™ ICM is the first insertable cardiac monitor with an indication for pediatric use in patients two years or older.

Explore the LINQ™ family of ICMs

Resources and downloads

Related products

™*Third-party brands are trademarks of their respective owners.

† In patients with syncope with low-risk features and after workup of patients with high-risk features.

‡ In analysis of Medicare claims of 1,323 patients.

§ Based on Kaplan-Meier estimates.

◊ Likely due to earlier initiation of therapy. Risk of mortality estimated by Kaplan-Meier curves. Cohorts of recurrent syncope patients with ICM were matched to control group based on syncope burden, age, gender, and Charlson Comorbidity index in German claims data. The control group underwent more diagnostic testing in the follow-up period than the ICM group, including 120% more 24h Holters. The cause of death is not recorded in the dataset and thus the share of cardiovascular deaths is not known.

¶ LINQ II™ ICM is indicated for patients two years and older.

LINQ II™ ICM ISW

Brief statement for LINQ II™ insertable cardiac monitor system (ICM) and accessories

Indications

Contraindications

Warnings and precautions

Potential adverse events or potential complications

Brief statement for AccuRhythm™ AI ECG classification system

Intended use

Contraindications

Precautions

Reveal LINQ™ ICM ISW

Brief statement for Reveal LINQ™ insertable cardiac monitor (ICM) system and accessories

Indications

Contraindications

Warnings and precautions

Potential adverse events or potential complications

AccuRhythm™ AI ECG classification system brief statement

Intended use

Contraindications

Precautions

Improving syncope pathways matters.

Guidelines recommend early use of ICM in unexplained syncope.†,5,6

Long-term, continuous monitoring with ICM results in:

When to consider ICM for unexplained syncope, per ESC and ACC/AHA/HRS guidelines:

Consider ICM for patients whose syncope symptoms may be misdiagnosed:

All ICMs are not created equal. Can you afford to miss an episode?

Discover the most accurate ICMs on the market.19–31

Detection algorithms

Proven technology

Small, discrete implant34

Fast, safe procedure

Available for pediatric syncope patients¶

Resources and downloads

Related products

United States

Customer Care Team

Guidelines recommend early use of ICM in unexplained syncope.^†,5,6

Discover the most accurate ICMs on the market.^19–31

Small, discrete implant³⁴

Available for pediatric syncope patients^¶