MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY VR, U1.6 DF1 US; Pulse generator, permanent, implantable

Model Number	CD1231-40
Medical Device Problem Codes	Environmental Compatibility Problem (2929); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that implantable cardioverter defibrillator (icd) went into bvvi mode.Upon further inquiry, was informed that the patient had undergone an mri scan.The device was restored.The backup therapy was not available.The patient is in stable condition.

• Brand Name: FORTIFY VR, U1.6 DF1 US
• Common Device Name: Pulse generator, permanent, implantable
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 21934447
• Report Number: 2017865-2025-51449
• Device Sequence Number: 5404622
• Product Code: NVZ
• UDI-Device Identifier: 05414734504355
• UDI-Public: (01)05414734504355(10)S000074202(17)210531
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2025

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: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: CD1231-40
• Device Catalogue Number: CD1231-40
• Device Lot Number: S000074202
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2019
• 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
• Patient Sex: Unknown