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TruaceTracing the truth around AISunday, July 12, 2026
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TRV-2026-0039Version 1 · Certified

Written 2026-07-12 20:50:17 UTC · current record

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TRUVACE RECORD VERSION
record: TRV-2026-0039
version: 1
kind: certified
reason: Certified into the record
timestamp: 2026-07-12T20:50:17.566660Z
status: published
lens: p_space
sector: health
headline: Linq ii¿ insertable cardiac monitor: FDA malfunction report involving AI
dek: 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.
gain_reading: (none)
problem_reading: 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.
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: Linq ii¿ insertable cardiac monitor; manufacturer: Medtronic singapore operations. | 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 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.

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 25093688 | https://api.fda.gov/device/event.json?search=mdr_report_key%3A%2225093688%22&sort=date_received%3Adesc&limit=1 | 2026-05-06
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