MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY DR, U1.6 SJ4 US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD2231-40Q
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	01/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented in-patient at the hospital.Upon device interrogation, the implantable cardioverter defibrillator was found in backup mode.Premature battery depletion was suspected.The device was explanted and replaced.The patient condition was stable.
Additional Manufacturer Narrative
The reported field event of backup operation was confirmed.The numerous high voltage charges performed in a short period of time by the device, resulted in resets from the high voltage controller integrated circuit.This caused the device to enter into backup mode.After the device was restored from backup mode, functional testing was normal.A longevity calculation was performed and found the battery depletion to be normal.

• Brand Name: FORTIFY DR, U1.6 SJ4 US
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 16275295
• Report Number: 2017865-2023-04653
• Device Sequence Number: 12016872
• Product Code: NVZ
• UDI-Device Identifier: 05414734504386
• UDI-Public: 05414734504386
• 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: 2019
• Device Explanted Year: 2023
• 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): 03/06/2023

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: 10/31/2020
• Device Model Number: CD2231-40Q
• Device Catalogue Number: CD2231-40Q
• Device Lot Number: S000069936
• 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: 01/13/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2019
• 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