A Subset of LINQ II ICMs Susceptible to Moisture Ingress

LINQ II Insertable Cardiac Monitoring Systems
Original Date of Communication: January 2022

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Medtronic has identified eight (8) LINQ II Insertable Cardiac Monitors (ICMs) distributed worldwide that may experience a loss of functionality. Medtronic has provided a communication to the eight healthcare professionals following a patient implanted with one of these ICMs.

Issue Description:

Medtronic has identified eight (8) LINQ II ICMs that may be susceptible to moisture ingress that could cause a loss of functionality prior to the recommended replacement time (RRT). Loss of functionality could result in the ICM failing to transmit and collect data. Potential harms include those associated with the risk of a delayed medical intervention, a missed diagnosis, or an explant procedure. Through 05-JAN-2022 there have been zero (0) complaints or harms reported as a result of this issue.

Patient Management Recommendations:

• For patients that are monitored on CareLink, LINQ II ICMs are designed to transmit nightly. When a transmission is not sent for 14 consecutive nights, the ICM will appear on the Disconnected Monitor list. If the ICM appears on this list, please contact Medtronic Technical Services for further assistance by calling < U.S. 1-800-929-4043>.
• Disconnected Monitors can be viewed from the Medtronic CareLink Network home page, under “Manage My Patient Views.”

• For patients not on CareLink, where more frequent in-clinic office visits are not an acceptable option for monitoring the patient, ICM replacement may be appropriate. Also consider whether enrolling the patient on CareLink is an option. Contact Medtronic Technical Services for assistance by calling < U.S. 1-800-929-4043>.

Specific Models This Applies To