LINQ II ICM Potential for Amplified Noise June 2024

LINQ II Insertable Cardiac Monitoring Systems
Original Date of Communication: June 2024

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STATUS UPDATE - OCTOBER 2024

As of 30 September 2024, Medtronic has identified 889 (1.37%) devices that have exhibited these characteristics, with zero (0) reports of serious harm. Medtronic estimates the projected rate of this issue to be 3.4% at 2 years or 8.7% at 4.5 years for the identified subset, and patient management recommendations are unchanged.

ORIGINAL COMMUNICATION - JUNE 2024

In November 2023, Medtronic communicated that a specific subset of LINQ II insertable cardiac monitors (ICMs) underwent a manufacturing process that may allow for moisture to impact electrode performance and create the potential for amplified noise and/or overall signal reduction of the ICM. This noise pattern is different from occasional noise due to device position/migration, patient activity, or external electromagnetic interference.

During continued investigation, Medtronic identified additional devices that have the potential for amplified noise. The identified subset now includes 64,700 total devices. Based on CareLink analysis and reported complaints as of 01 May 2024, 553 (0.85%) devices have exhibited these characteristics, with zero (0) reports of serious harm. Medtronic estimates the projected rate of this issue to be 2.9% at 2 years or 6.2% at 4.5 years for the identified subset. If an amplified noise pattern occurs, potential harms include missed/delayed diagnosis, delayed medical intervention, and early device replacement. Medtronic recently implemented manufacturing changes to address this issue. Overall LINQ II freedom from malfunction, including this issue, is projected to be 98.51% at 4.5 years.

PATIENT MANAGEMENT RECOMMENDATIONS:

In consultation with our Independent Physician Quality Panel (IPQP), Medtronic emphasizes continued care of patients implanted with an ICM per the existing device labeling. These recommendations are reflective of the November 2023 communication.

• Please encourage enrollment in and regular transmissions to CareLink.
  • Medtronic will continue to apply recurring algorithmic searches on CareLink for the specific amplified noise pattern and notify the clinician if present. No further action is required for patients regularly transmitting to CareLink.
• For patients not followed in CareLink:
  • Consider whether enrolling in CareLink is an option, per HRS/EHRA/APHRS/LAHRS guidance.¹ CareLink monitoring will reduce the potential for episodes caused by amplified noise to overwrite true episodes before they are reviewed.
  • If noise interferes with the ability to assess the patient’s rhythm or reason for monitoring, contact Medtronic Technical Services for assistance (dxhelp@medtronic.com or 1-800-929-4043).
• If the ICM is no longer in use, no further action is necessary.

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