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 Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implantable cardioverter defibrillator (icd) exhibited premature discharge of battery.The icd was explanted and replaced.The patient was in stable condition.
Additional Manufacturer Narrative
A device history record (dhr) review was performed, and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities and all quality control tests prior to its distribution.
Additional Manufacturer Narrative
Reported event of premature discharge of battery was not confirmed.The device voltage was at end of service (eos) level upon receipt.A longevity calculation was performed and found the battery depletion was normal based on the device usage.Analysis of the device image indicated the device was within normal range of operation.Further analysis of the device¿s telemetry, lead impedance, pacing, sensing, and high voltage charging were found to be normal.A device history record (dhr) review was performed, and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities and all quality control tests prior to its distribution.

• 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: 22172642
• Report Number: 2017865-2025-85806
• Device Sequence Number: 9218512
• Product Code: NVZ
• UDI-Device Identifier: 05414734504355
• UDI-Public: (01)05414734504355(10)A000114963(17)230331
• 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: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2026

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: 03/31/2023
• Device Model Number: CD1231-40
• Device Catalogue Number: CD1231-40
• Device Lot Number: A000114963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 06/11/2025; 03/04/2026
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 06/11/2025; 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2021
• 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