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

Model Number	419488
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: 407658 lead implanted (b)(6) 2009; dtpa2d1 crt-d implanted (b)(6) 2025.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 in use for pacing and sensing exhibited high thresholds and high undefined impedance.It was reported that the rv lead in use for defibrillation exhibited high undefined impedance on both defibrillation coils.The leads were capped and a new lead was implanted for pacing and defibrillation.It was also reported that the right atrial (ra) lead exhibited high thresholds.The lead was capped and replaced.It was also reported that the left ventricular (lv) lead exhibited high undefined impedance.The lead was capped with no replacement.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: 25620308
• Report Number: 2649622-2026-18928
• Device Sequence Number: 9094250
• Product Code: LWP
• UDI-Device Identifier: 00885074113371
• UDI-Public: (01)00885074113371(17)071027
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P010015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2026
• 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): 06/25/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/27/2007
• Device Model Number: 419488
• Device Catalogue Number: 419488
• 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: 06/02/2026
• Initial Report FDA Received Date: 06/25/2026
• Date Device Manufactured: 11/01/2005
• 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: 694965 LEAD, 5076-52 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 89 KG