aceReveal linq: FDA malfunction report involving AI
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.
Customer concern that the Reveal LINQ implantable monitor's AI adjudication classified true pause episodes as false, following undersensing and false pause episodes
Single MAUDE malfunction report; does not establish causality, incidence rate, or clinical outcome
Evidence
- GovernmentFDA MAUDE report 244672412026-02-27
How should this claim be treated?
Truvace Impact Record TRV-2026-0041, v2: “Reveal linq: FDA malfunction report involving AI.” Truvace, 2026-07-13. /record/TRV-2026-0041 (accessed at citation time). sha256 d100d75a85e71578…
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