MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION CAPSURE EPICARDIAL LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number	4968-35
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the left ventricular (lv) lead was plugged into the right atrial (ra) lead port and the ra lead was plugged into the lv port on the cardiac resynchronization therapy pacemaker (crt-p).It was also reported that the ra lead exhibited a suspected fracture and far field r-wave (ffrw) oversensing and failed an atrial lead position check.It was also reported that the ra lead triggered an alert for out of range (oor) high impedance.  the patient then underwent a sternotomy procedure to revise the ra lead.It was then reported after the procedure, that the rv lead had triggered an alert for oor high impedance.It was further reported that lead was not fully seated in the crt-p header.The crt-p and leads remain in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: w1tr01 ipg implanted (b)(6) 2025.Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the impedance of the right ventricular pacing lead was beyond the expected upper range.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.

• Brand Name: CAPSURE EPICARDIAL LEAD
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 24302748
• Report Number: 2182207-2026-00318
• Device Sequence Number: 15866262
• Product Code: DTB
• UDI-Device Identifier: 00681490116725
• UDI-Public: (01)00681490116725(17)121114
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P950024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/14/2012
• Device Model Number: 4968-35
• Device Catalogue Number: 4968-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4968-35 LEAD, 4968-35 LEAD
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 59 KG