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

Model Number	429878
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Tachycardia (2095); Syncope/Fainting (4411)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient that they were in the hospital because of a fainting spell and "passed out" the day prior.The patient stated that "they showed a tachycardia or something in my heart thing".Additionally, the patient mentioned the physician that implanted the cardiac resynchronization therapy defibrillator (crt-d) said one of the leads was not placed right in their "first one" and when the patient fainted, the defibrillation "did not go off".The patient also stated the left ventricular (lv) lead was not placed properly so instead of going in to reconnect the lead, "it was hard for them to sync between the right ventricular (rv) lead and the lv lead".In addition, the patient said that when they were in the hospital, the staff told them that the reason they fainted was because of atrial fibrillation (af) and that their device should have gone off.The crt-d remains in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: dtpa2q1 crt-d implanted: (b)(6) 2021.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) P
• 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: 24368743
• Report Number: 2649622-2026-04620
• Device Sequence Number: 9471364
• Product Code: OJX
• UDI-Device Identifier: 00643169002685
• UDI-Public: (01)00643169002685(17)170415
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P080006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2026

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: 04/15/2017
• Device Model Number: 429878
• Device Catalogue Number: 429878
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 02/17/2026
• Date Device Manufactured: 05/15/2015
• 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: 693558 LEAD, 5076-45 LEAD
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 77 YR
• Patient Sex: Female