MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA SCREW-IN LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number	5071-35
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Device Overstimulation of Tissue (1991)
Date of Event	12/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: dtpa2d1 crtd implanted: (b)(6)2023.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 since the last device changeout, the patient had experienced cardiac stimulation with left ventricular (lv) pacing.Reprogramming was performed to resolve the stimulation issue.It was further reported that the patient complained of being chronically tired and having shortness of breath.A review of the device data by qualified personnel determined that there was lead polarization occurring which was compromising the device's effectivecrt feature.The left ventricular (lv) lead and cardiac resynchronization therapy defibrillator (crt-d) remain in use.No further patient complications have been reported as a result of this event.

• Brand Name: SCREW-IN 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: 23076443
• Report Number: 2649622-2025-25858
• Device Sequence Number: 9737991
• Product Code: DTB
• UDI-Device Identifier: 00681490124379
• UDI-Public: (01)00681490124379(17)090510
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P120017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• 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): 09/17/2025

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: 05/10/2009
• Device Model Number: 5071-35
• Device Catalogue Number: 5071-35
• 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: 08/25/2025
• Initial Report FDA Received Date: 09/17/2025
• Date Device Manufactured: 05/12/2005
• 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: 507652 LEAD, 694765 LEAD, 6937A52 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 118 KG