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 Codes	Failure to Capture (1081); Extracardiac stimulation (1463); Low impedance (2285); High Capture Threshold (3266)
Health Effect - Clinical Codes	No Clinical Signs, Symptoms or Conditions (4582); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) battery was depleting faster than expected due to low impedance on the right ventricular (rv), right atrial (ra), and left ventricular (lv) leads as well as high lv thresholds.The system remains in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: dtpa2d1 crt-d implanted (b)(6) 2024.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 further reported that the three leads had chronic low impedances and the lv lead had chronic high thresholds with no other options for changes due to loss of capture or phrenic pacing with other vectors.The only thing that was able to be changed was the lv lead threshold output, which was decreased to save a little more battery.
Additional Manufacturer Narrative
Corrections: b1, b2, b5, h1, h6 annex a/e/f 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: 23535018
• Report Number: 2649622-2025-31854
• Device Sequence Number: 10186721
• Product Code: LWP
• UDI-Device Identifier: 00885074113371
• UDI-Public: (01)00885074113371(17)120908
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P010015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: 09/08/2012
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 02/11/2026
• Date Device Manufactured: 09/21/2010
• 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: 694758 LEAD, 407645 LEAD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female