MAUDE Adverse Event Report: MPRI CAPSUREFIX LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number	5568-53
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Pacing Problem (1439); Under-Sensing (1661)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the patient experienced chest pain.An interrogation report indicated that the right atrial (ra) lead position check failed and the ra lead exhibited undersensing resulting in false termination of atrial tachycardia/atrial fibrillation (at/af) detection, inappropriate pacing and misclassification of ventricular tachycardia non-sustained and supra ventricular tachycardia (svt) episodes.In addition, the inappropriate ra pacing lead to a blanked ventricular event that caused a functional loss of right ventricular (rv) lead capture of ventricular paced event.The ra and the rv lead remain in use.No further patient complications have been reported as a result of this event.

• Brand Name: CAPSUREFIX LEAD
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 21897677
• Report Number: 2649622-2025-11026
• Device Sequence Number: 11623729
• Product Code: DTB
• UDI-Device Identifier: 00613994776853
• UDI-Public: 00613994776853
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P930039
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2025

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: 06/09/2013
• Device Model Number: 5568-53
• Device Catalogue Number: 5568-53
• 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: 04/03/2025
• Initial Report FDA Received Date: 04/24/2025
• Date Device Manufactured: 06/29/2011
• 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: 5076-58 LEAD, W1DR01 IPG
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 113 KG