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

Model Number	5071-35
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the right atrial (ra) lead exhibited undersensing during atrial tachycardia/atrial fibrillation (at/af) stored episodes resulting in termination of at/af detected event(s) in progress and causing unnecessary atrial pacing.It was also reported that the left ventricular (lv) lead exhibited low impedance.Additionally, the cardiac resynchronization therapy defibrillator (crt-d) triggered a false observation for an increase in the lv lead threshold indicating that the increase was greater than the amplitude safety margin and may have compromised capture.The observation displayed question marks where a numerical value would typically be displayed.The ra lead, lv lead, and crt-d remain in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: dtma1d4 crt-d, implanted: (b)(6) 2022, 6935m62 lead , implanted: (b)(6) 2022.5867-3m adaptor, implanted: (b)(6) 2022.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 24912510
• Report Number: 2649622-2026-11027
• Device Sequence Number: 21281986
• Product Code: DTB
• UDI-Device Identifier: 00643169638594
• UDI-Public: (01)00643169638594(17)220831
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P120017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 04/17/2026

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: 08/31/2022
• 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: 03/27/2026
• Initial Report FDA Received Date: 04/17/2026
• Date Device Manufactured: 09/27/2018
• 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: 5071-35 LEAD.
• Patient Age: 73 YR
• Patient Sex: Female