MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA CAPSURE SP NOVUS LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number	5092-58
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/19/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Continuation of d10: 407652 lead implanted (b)(6) 2009.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 died.The patient's representative mentioned that the "patient flatlined and asked if medtronic saw anything".Additional information related to the cause of death was requested and not received.

• Brand Name: CAPSURE SP NOVUS LEAD
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO VILLALBA; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MEDTRONIC PUERTO RICO VILLALBA; 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: 24107263
• Report Number: 2649622-2026-01516
• Device Sequence Number: 21276199
• Product Code: DTB
• UDI-Device Identifier: 00681490125109
• UDI-Public: (01)00681490125109(17)090827
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P850089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/27/2009
• Device Model Number: 5092-58
• Device Catalogue Number: 5092-58
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2025
• Initial Report FDA Received Date: 01/19/2026
• Date Device Manufactured: 09/18/2007
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 65 YR
• Patient Sex: Male