MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA ATTAIN BIPOLAR OVER THE WIRE LEAD; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	419478
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Purulent Discharge (1812); Unspecified Infection (1930)
Date of Event	05/11/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient experienced an infection with erosion and purulent discharge observed.During the attempted explant of the cardiac resynchronization therapy defibrillator (crt-d) system, the patient expired during extraction of the right atrial (ra) lead.It was noted that the other two leads were successfully removed, however the ra lead caused a complication.It was noted that during right atrial lead extraction, it was perceived that a perforation was created when the atrial lead was removed.
Additional Manufacturer Narrative
Continuation of d10: product id: 6935m62 lead implanted: on (b)(6) 2017, explanted: on (b)(6) 2026, product id: 5568-45 lead implanted: on (b)(6) 2005, explanted: on (b)(6) 2026, product id: dtma1d4 crt-d, implanted: on (b)(6) 2024, explanted: on (b)(6) 2026.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: ATTAIN BIPOLAR OVER THE WIRE LEAD
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 25446546
• Report Number: 2649622-2026-17038
• Device Sequence Number: 15842064
• Product Code: LWP
• UDI-Device Identifier: 00885074113364
• UDI-Public: (01)00885074113364(17)070519
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P010015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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: 05/19/2007
• Device Model Number: 419478
• Device Catalogue Number: 419478
• 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: 05/11/2026
• Initial Report FDA Received Date: 06/09/2026
• Date Device Manufactured: 05/25/2005
• 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: "SEE H11."
• Outcome Attributed to Adverse Event: Death
• Patient Age: 82 YR
• Patient Sex: Male