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	Premature Discharge of Battery (1057); Inappropriate/Inadequate Shock/Stimulation (1574); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient presented to clinic for follow up.The implantable cardioverter defibrillator (icd) was unable to be interrogated.It was noted that there was inappropriate therapy and premature battery depletion.The physician elected to explant and replace the icd.The patient condition was stable.
Additional Manufacturer Narrative
The reported event of backup operation was confirmed.Analysis of the device image found the device went into backup mode due to power-on reset as a result of low battery voltage.The device performed numerous high voltage charges for high voltage therapy.The cause of backup operation was consistent with low battery voltage resulting from numerous high voltage charges.After the device was restored from backup mode, functional testing was performed.Telemetry, impedance, sensing, and pacing output functions of the device were tested and found to be normal.

• 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: 18581536
• Report Number: 2017865-2024-02020
• Device Sequence Number: 12823728
• Product Code: NVZ
• UDI-Device Identifier: 05414734504355
• UDI-Public: 05414734504355
• 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): 02/21/2024

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: 11/30/2023
• Device Model Number: CD1231-40
• Device Lot Number: A000125989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• 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: Not provided
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2022
• 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: Other; Required Intervention
• Patient Sex: Unknown