Medtronic Lead

Description of Event or Problem

Literature was reviewed regarding a lead revision. The authors described a patient who presented approximately fifty-six days post implant with intermittent loss of left ventricular pacing. Interrogation revealed low P wave amplitude which resulted in atrial undersensing which led to failure of atrial sensing and subsequent inhibition of biventricular pacing. The Right Atrial (RA) lead also exhibited high thresholds and a micro dislodgement was suspected. The RA lead was explanted and replaced. No adverse patient effects or additional product performance issues were reported.

Additional Manufacturer Narrative

This information is based entirely on journal literature. Medtronic was made aware of this event through a search of literature publications. This event occurred outside the US. Patient information is limited due to confidentiality concerns. The event only occurred with one patient but specific details on the patient were not provided. The model listed in the report is a representative of the model family, as there is no specific model listed. Without a serial number, the manufacturing date cannot be determined. Since no device ID was provided, it is unknown if this event has been previously reported. A request for additional information was made. If additional information is obtained regarding this event, it will be added, and a supplemental report will be submitted accordingly. Referenced article: The first human pocket histology at an eight-week cardiac implantable electronic device with absorbable antibacterial envelope: case report. European Heart Journal - Case Reports. 2026. 10, ytaf651. DOI: 10.1093/ehjcr/ytaf651 Medtronic submits this report to comply with FDA regulations 21 CFR Parts 4 and 803. Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by FDA, Medtronic, or its employees that the device, Medtronic, or its employee caused or contributed to the event described in the report. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. Medtronic will submit a supplemental report if additional relevant information becomes known.