Reveal linq: FDA malfunction report involving AI
The FDA received a malfunction report involving Reveal linq, made by Medtronic europe sarl. It was reported that the implantable cardiac monitor (icm) experienced false pause episodes due to undersensing. it was reported that representative stated the customer is concerned that the artificial intelligence (ai) algorithm adjudicated some pause episodes as false when they determined to be true. the icm remains in the patient. no patient complications have been reported as a result of this event.
An FDA adverse-event report linked Reveal linq to an AI-related malfunction; the report requires investigation and does not by itself establish causality.
FDA adverse-event reports can be incomplete, duplicated, or unverified and do not establish that a device caused the reported outcome.
Evidence
- GovernmentFDA MAUDE report 244672412026-02-27
Truvace Impact Record TRV-2026-0041, v1: “Reveal linq: FDA malfunction report involving AI.” Truvace, 2026-07-12. /record/TRV-2026-0041 (accessed at citation time). sha256 7682fc076a07bbab…
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