aceTRV-2026-0041Version 1 · Certified
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TRUVACE RECORD VERSION record: TRV-2026-0041 version: 1 kind: certified reason: Certified into the record timestamp: 2026-07-12T20:50:17.695163Z status: published lens: p_space sector: health headline: Reveal linq: FDA malfunction report involving AI dek: 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. gain_reading: (none) problem_reading: An FDA adverse-event report linked Reveal linq to an AI-related malfunction; the report requires investigation and does not by itself establish causality. limitation: FDA adverse-event reports can be incomplete, duplicated, or unverified and do not establish that a device caused the reported outcome. tag: Evidence-backed problem key_points: Device: Reveal linq; manufacturer: Medtronic europe sarl. | FDA report type: Malfunction. | An adverse-event report is a safety signal, not proof that the device caused the event. rundown: 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. The report is part of FDA’s MAUDE surveillance data. It should be read as a signal for follow-up, not a clinical conclusion or a verified incidence rate. sources: - government | FDA MAUDE report 24467241 | https://api.fda.gov/device/event.json?search=mdr_report_key%3A%2224467241%22&sort=date_received%3Adesc&limit=1 | 2026-02-27 prev: 0000000000000000000000000000000000000000000000000000000000000000
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