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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the proximal portion of the lead was returned and analyzed.The analysis indicated that the lv1/distal conductor was fractured in-vivo in the anchoring sleeve area.The outer insulation of the lead developed a breach due to metal ion oxidation while in vivo.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 high thresholds and slightly elevated bipolar pacing impedance.It was observed on x-ray that the rv lead helix was likely perforated and there was a possibly exposed wire or externalized conductor from the lead insulation.The rv lead was capped and replaced. it was additionally noted that the patient's system with the rv lead was programmed to pace at forty beats per minute with arrhythmia detections off versus the rv lead having been capped as previously reported.It was later noted that the rv lead was removed.The left ventricular (lv) lead, which was removed due to the associated rv lead, had no product performance allegation but was returned to the manufacturer and subsequently tested out of specification during manufacturer's analysis.No patient complications have been reported as a result of this event.

• 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: 25119746
• Report Number: 2649622-2026-13324
• Device Sequence Number: 10729000
• Product Code: LWP
• UDI-Device Identifier: 00885074113364
• UDI-Public: (01)00885074113364(17)101203
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P010015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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: 12/03/2010
• Device Model Number: 419478
• Device Catalogue Number: 419478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2009
• 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: DTMB1D1 CRT-D
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 68 KG