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

Model Number	5071-53
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Codes	Stroke/CVA (1770); Loss of consciousness (2418)
Date of Event	02/09/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the right ventricular (rv) epicardial leads exhibited loss of capture on the current electrograms (egm), oversensing with sensed events noted post ventricular blanking, and oversensing of noise resulting in inhibition of pacing.It was noted that the patient had an altered mental status and was unresponsive.It was further reported that approximately a month prior, the cardiac resynchronization therapy defibrillator (crt-d) experienced electromagnetic interference from an external, unknown source.The crt-d remains in use.The crt-d and rv epicardial leads remains in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: dtpa2d1 crt-d implanted: (b)(6) 2023 6721m-50 lead implanted: (b)(6) 2019.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 patient was paced below the lower programmed rate due to the right ventricular (rv) leads sensing outside of the blanking period.Additionally, the patient experienced a stroke and ultimately passed away.
Additional Manufacturer Narrative
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: 25107701
• Report Number: 2649622-2026-13181
• Device Sequence Number: 9326785
• Product Code: DTB
• UDI-Device Identifier: 00643169638600
• UDI-Public: (01)00643169638600(17)230122
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 05/29/2026

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: 01/22/2023
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 05/29/2026
• Date Device Manufactured: 02/04/2019
• 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, 5071-53 LEAD, 5071-53 LEAD
• Outcome Attributed to Adverse Event: Death; Life Threatening
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 61 KG