MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY ASSURA VR ICD, US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	CD1357-40C
Medical Device Problem Codes	Failure to Interrogate (1332); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an asymptomatic patient presented in clinic for follow-up.A device interrogation was performed and revealed that the patient's implantable cardioverter defibrillator (icd) had inappropriately gone into backup operation with high voltage therapies disabled.It was noted that the backup operation was caused by power on reset (por).The icd was attempted to be reset but was unsuccessful.The patient later presented again for follow up where it was discovered that their icd failed to be interrogated.The icd was explanted and replaced.The patient was stable.
Event or Problem Description
Additional information received indicated that the implantable cardioverter defibrillator failed to be interrogated using radio frequency telemetry or inductive telemetry.
Additional Manufacturer Narrative
Reported events of no rf telemetry and no inductive telemetry were confirmed.Reported event of por related reset was not confirmed.The device was received with no output and no telemetry communication.The device was cut open to enable further testing and the battery was found at end-of-service level.Further testing after replacing the battery revealed no indications of high current drain.Electrical and mechanical test results indicated normal device functionality.The device¿s battery was sent to the vendor for destructive analysis and no anomalies were found.No battery defects were identified during the destructive analysis that would account for premature battery depletion.Further hybrid testing performed with an external power source did not identify any functional issues.

• Brand Name: FORTIFY ASSURA VR ICD, US
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 23028261
• Report Number: 2017865-2025-99879
• Device Sequence Number: 9820405
• Product Code: LWS
• UDI-Device Identifier: 05414734507943
• UDI-Public: (01)05414734507943(10)A000062431(17)200731
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/06/2026

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: 07/31/2020
• Device Model Number: CD1357-40C
• Device Catalogue Number: CD1357-40C
• Device Lot Number: A000062431
• 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: 08/25/2025
• Supplement Date Received by Manufacturer: 09/12/2025; 09/12/2025; 01/05/2026
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 09/12/2025; 09/15/2025; 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2018
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 69 KG