MAUDE Adverse Event Report: Medtronic Puerto Rico Villalba Sprint Quattro Secure MRI SureScan; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	6947M55
Medical Device Problem Codes	Fracture (1260); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: dtpa2d4 crt-d, implanted: (b)(6) 2026.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 ventricular (rv) lead exhibited an apparent fracture.It was also reported that the cardiac resynchro nization therapy defibrillator (crt-d) setscrew was noted to be sideways in the port, observed to be misaligned.In addition, there was high rv pacing impedance that was noted.However, further investigation noted that the rv lead performance was okay as it turned out that the crt-d set screw was misaligned.The crt-d was explanted and replaced, and the rv lead remains implanted active.No patient complications have been reported as a result of this event.

• Brand Name: Sprint Quattro Secure MRI SureScan
• Common Device Name: PERMANENT DEFIBRILLATOR ELECTRODES
• 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--439 ; +1(763)526-9277
• MDR Report Key: 50500879
• Report Number: 2649622-2026-25596
• Device Sequence Number: 10087996
• Product Code: NVY
• UDI-Device Identifier: 00643169082243
• UDI-Public: (01)00643169082243(17)150528
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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: 05/28/2015
• Device Model Number: 6947M55
• Device Catalogue Number: 6947M55
• 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: 08/12/2026
• Initial Report FDA Received Date: 08/28/2026
• Date Device Manufactured: 06/07/2013
• 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: 407645 LEAD, 439688 LEAD
• Patient Age: 63 YR
• Patient Sex: Female