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	Failure to Convert Rhythm (1540); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced an arrhythmia.Upon review, it was noted that the implantable cardioverter defibrillator (icd) delivered high voltage therapy but the patient's rhythm was unable to be converted.The patient received external defibrillation on (b)(6) 2024 and the arrhythmia was successfully converted.On (b)(6) 2024, the icd was found to be in back-up mode with no back-up defibrillation option (bdfo) available.The icd was successfully restored.On (b)(6) 2024, the icd was explanted and replaced.The patient was in stable condition.
Additional Manufacturer Narrative
The reported field event of backup operation was confirmed.Reports from the field confirm the device underwent an external defibrillation and went into backup operation.The device firmware had been restored in the field before being received.Memory testing was performed, and no anomalies were found.Telemetry, impedance, sensing, pacing, and high voltage (hv) output functions of the device were tested and found to be normal.The backup operation was not reproduced during the analysis.The cause of the reported event was consistent with external conditions.

• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 20645797
• Report Number: 2017865-2024-69377
• Device Sequence Number: 7506671
• Product Code: NVZ
• UDI-Device Identifier: 05414734504355
• UDI-Public: (01)05414734504355(10)A000113142(17)230131
• 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: 2024
• 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): 02/17/2025

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: 01/31/2023
• Device Model Number: CD1231-40
• Device Lot Number: A000113142
• 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: 10/22/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• 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; Life Threatening
• Patient Sex: Unknown