aceTRV-2026-0039Version 1 · Certified
Reason for this version
Certified into the record
Canonical text (the exact bytes fingerprinted)
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 prev: 0000000000000000000000000000000000000000000000000000000000000000
- sha256
- b2cf1d3d9add489db66c7d9e8f7da6c17040431df399259cd530d865849cf462
- previous
- 0000000000000000000000000000000000000000000000000000000000000000
Verify this record
How to verify without trusting this page
Fetch the canonical text of any version from /api/record/TRV-2026-0039 and hash it yourself — for example shasum -a 256 on the saved canonical field. The result must equal content_hash, and each version’s text ends with prev:followed by the prior version’s hash (version 1 chains to 64 zeros). If a single character of any version had been altered since certification, the chain would not reproduce.