aceLinq ii¿ insertable cardiac monitor: FDA malfunction report involving AI
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.
An FDA malfunction report described the Linq II insertable cardiac monitor's AI algorithm rejecting true pause episodes and generating false ventricular tachycardia detections, with no complications reported to date.
Single MAUDE malfunction report; does not establish causality, incidence rate, or clinical outcome impact.
Evidence
- GovernmentFDA MAUDE report 250936882026-05-06
How should this claim be treated?
Truvace Impact Record TRV-2026-0039, v2: “Linq ii¿ insertable cardiac monitor: FDA malfunction report involving AI.” Truvace, 2026-07-13. /record/TRV-2026-0039 (accessed at citation time). sha256 1af519f01989ef2d…
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