MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA SPRINT QUATTRO MRI SURESCAN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	6946M55
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date is approximate.Month and year are confirmed valid.Continuation of d10: 383069 lead implanted: (b)(6) 2022 evfxplus-29 valve implanted: (b)(6) 2024, 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.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 oversensing.Noise and non-physiologic oversensing including pacing i nhibition was also observed.A fracture was suspected.The rv lead remains in use.No patient complications have been reported as a result of this event.

• Brand Name: SPRINT QUATTRO MRI SURESCAN
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 22800601
• Report Number: 2649622-2025-22005
• Device Sequence Number: 12840811
• Product Code: LWS
• UDI-Device Identifier: 00643169858305
• UDI-Public: (01)00643169858305(17)200626
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/13/2025

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: 06/26/2020
• Device Model Number: 6946M55
• Device Catalogue Number: 6946M55
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 08/13/2025
• Date Device Manufactured: 08/07/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DTMA1D4 CRT-D, 5076-45 LEAD, 5867-3M ADAPTOR.
• Patient Age: 81 YR
• Patient Sex: Female