MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY VR, U1.6 SJ4 US; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	CD1231-40Q
Medical Device Problem Codes	Premature Discharge of Battery (1057); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for in clinic follow up.Device interrogation revealed that the implantable cardioverter defibrillator (icd) was in backup vvi mode.The device's battery had prematurely depleted after providing constant appropriate shock therapy.The physician elected to explant and replace the icd.There were no patient consequences.

• Brand Name: FORTIFY VR, U1.6 SJ4 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: 21573843
• Report Number: 2017865-2025-16800
• Device Sequence Number: 8751968
• Product Code: NVZ
• UDI-Device Identifier: 05414734504348
• UDI-Public: (01)05414734504348(10)S000073004(17)210228
• 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
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: CD1231-40Q
• Device Catalogue Number: CD1231-40Q
• Device Lot Number: S000073004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown