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TRV-2026-0040Version 1 · Certified

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

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TRUVACE RECORD VERSION
record: TRV-2026-0040
version: 1
kind: certified
reason: Certified into the record
timestamp: 2026-07-12T20:50:17.637380Z
status: published
lens: p_space
sector: health
headline: Accurhythm za420 (pause): FDA malfunction report involving AI
dek: The FDA received a malfunction report involving Accurhythm za420 (pause), made by Medtronic, inc.. It was reported that true pause episodes were rejected as false by the artificial intelligence (ai) algorithm. no patient complications have been reported as a result of this event.
gain_reading: (none)
problem_reading: An FDA adverse-event report linked Accurhythm za420 (pause) 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: Accurhythm za420 (pause); manufacturer: Medtronic, inc.. | 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. 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 24996227 | https://api.fda.gov/device/event.json?search=mdr_report_key%3A%2224996227%22&sort=date_received%3Adesc&limit=1 | 2026-04-27
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