Linq ii¿ insertable cardiac monitor: FDA malfunction report involving AI
The FDA received a malfunction report involving Linq ii¿ insertable cardiac monitor, made by Medtronic singapore operations. It was reported that true pause episodes were rejected as false by the artificial intelligence (ai) algorithm. it was further reported that the implantable cardiac monitor (icm) detected false ventricular tachycardia (vt) episodes. the icm remains in use. no patient complications have been reported as a result of this event.
An FDA adverse-event report linked Linq ii¿ insertable cardiac monitor 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 250936882026-05-06
Truvace Impact Record TRV-2026-0039, v1: “Linq ii¿ insertable cardiac monitor: FDA malfunction report involving AI.” Truvace, 2026-07-12. /record/TRV-2026-0039 (accessed at citation time). sha256 b2cf1d3d9add489d…
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