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

Model Number	5071-53
Medical Device Problem Codes	Intermittent Capture (1080); Fracture (1260); High impedance (1291); Over-Sensing (1438); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the right ventricular (rv) lead triggered a lead integrity alert (lia) due to sensing integrity counter (sic) and high-rate non-sustained episodes.Additionally, it was reported that the rv lead exhibited high/undefined impedance, oversensing, noise, and a small decrease in tip-to-coil impedance measurements overtime.It was also noted that the left ventricular (lv) lead was nicked during a prior procedure and repaired with a chemical adhesive at that time.Additionally, it was reported that the lv lead is plugged into the r lead port and is fractured.The rv lead is plugged into the lv lead port and is fractured.The right atrial (ra) lead is fractured and exhibited high, undefined impedance.The ra lead also did not have reliable sensing and exhibited intermittent capture.It was also noted that the ra lead exhibited crosstalk and was reprogrammed.No further intervention was taken as the patient is awaiting transplant.The ra lead, rv lead and lv lead remain 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 5071-53 lead implanted: (b)(6) 2011 6996sq58 lead implanted: (b)(6) 2011 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.
Additional Manufacturer Narrative
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the impedance of the atrial pacing lead was beyond the expected upper range.The device memory indicated diminished atrial sensing.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: 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: 23769630
• Report Number: 2649622-2025-34457
• Device Sequence Number: 9750601
• Product Code: DTB
• UDI-Device Identifier: 00681490124454
• UDI-Public: (01)00681490124454(17)140623
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P120017
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: 06/23/2014
• Device Model Number: 5071-53
• Device Catalogue Number: 5071-53
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2010
• 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: 5071-53 LEAD, 4968-60 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 97 KG