MAUDE Adverse Event Report: Medtronic Puerto Rico Villalba Sprint Quattro Secure MRI SureScan; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	694758
Medical Device Problem Codes	Over-Sensing (1438); Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2026
Type of Reportable Event	Malfunction

• Brand Name: Sprint Quattro Secure 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--439 ; +1(763)526-9277
• MDR Report Key: 50070674
• Report Number: 2649622-2026-22382
• Device Sequence Number: 13316186
• Product Code: LWS
• UDI-Device Identifier: 00613994249876
• UDI-Public: (01)00613994249876(17)130517
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 08/06/2026

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: 05/17/2013
• Device Model Number: 694758
• Device Catalogue Number: 694758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2026
• Supplement Date Received by Manufacturer: 07/18/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 08/06/2026
• Date Device Manufactured: 05/27/2011
• 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
• Patient Age: 60 YR
• Patient Sex: Female