MAUDE Adverse Event Report: MPRI CAPSURE EPICARDIAL LEAD; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)

Model Number	4965-25
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); High impedance (1291); Low impedance (2285)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	02/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 atrial pacing lead was below the expected lower range.Analysis of the device memory indicated the impedance of the atrial pacing lead was beyond the expected upper range.The device memory indicated an issue with the atrial lead position check.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 right ventricular (rv) lead exhibited both intermittent and complete loss of capture and was noted to not be pacing.There is multiple short circuit pace (scp) or open circuit pace (ocp) counts on right atrial (ra) lead and rv lead.The ra lead also had a atrial lead position check fail.There was also a false trigger alert for atrial lead impedance out of range on the implantable pulse generator (ipg) device.The patient experienced symptoms of bradycardia, with heart rate at forty beats per minute.The rv lead was reprogrammed.The implantable pulse generator (ipg) system remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: CAPSURE EPICARDIAL LEAD
• Common Device Name: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)
• 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: 21523709
• Report Number: 2649622-2025-06274
• Device Sequence Number: 15548228
• Product Code: NVN
• UDI-Device Identifier: 00613994501745
• UDI-Public: 00613994501745
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P950024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/05/2025

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: 02/10/2025
• Device Model Number: 4965-25
• Device Catalogue Number: 4965-25
• 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: 02/13/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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: W1DR01 IPG, 4968-25 LEAD
• Patient Age: 7 MO
• Patient Sex: Female
• Patient Weight: 7 KG