MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA ATTAIN PERFORMA MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number	429878
Medical Device Problem Codes	Failure to Capture (1081); Impedance Problem (2950); High Capture Threshold (3266)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/10/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the right atrial (ra) lead displayed undersensing resulting in unnecessary pacing at times and false termination of atrial tachycardia/atrial fibrillation (at/af) events.Approximately three days later, the patient passed away.A remote monitoring transmission was sent the next day and indicated there were high ra lead and left ventricular (lv) lead thresholds.Additionally, the ra lead, lv lead, and right ventricular (rv) lead displayed a loss of capture in pacing impedances.
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.
Event or Problem Description
It was reported that the right atrial (ra) lead displayed undersensing resulting in unnecessary pacing at times and false termination of atrial tachycardia/atrial fibrillation (at/af) events.Approximately three days later, the patient passed away.A remote monitoring transmission was sent the next day and indicated there were high right ventricular (rv) lead and left ventricular (lv) lead thresholds.Additionally, the ra lead, lv lead, and rv lead displayed a loss of capture and rising pacing impedances.
Additional Manufacturer Narrative
Correction: b5.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 PERFORMA MRI SURESCAN
• Common Device Name: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) 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: 24849141
• Report Number: 2649622-2026-10332
• Device Sequence Number: 8825706
• Product Code: OJX
• UDI-Device Identifier: 00643169601826
• UDI-Public: (01)00643169601826(17)210703
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P080006
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2026

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: 07/03/2021
• Device Model Number: 429878
• Device Catalogue Number: 429878
• 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: 03/14/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 06/10/2026
• Date Device Manufactured: 07/24/2019
• 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: W4TR02 CRT-P, 407652 LEAD, 407645 LEAD
• Outcome Attributed to Adverse Event: Death
• Patient Age: 77 YR
• Patient Sex: Female