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 Code	Failure to Charge (1085)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
It was reported that the implantable cardioverter defibrillator (icd) exhibited charge time out.The physician explanted and replaced the icd.The patient condition was unknown.
Additional Manufacturer Narrative
The reported event of charge timeout was confirmed.The device was received at end-of-life battery voltage level, with normal output and telemetry communication.Analysis of the device image indicates the device was implanted beyond its projected longevity and underwent multiple high voltage charging and shock events.These conditions significantly increase energy consumption, thereby accelerating battery depletion and affecting charging time of the high voltage capacitor.The charge timeout was reproduced during lab testing, consistent with end-of-life battery voltage condition.The device was implanted for 11.79 years which exceeded its projected longevity and is consistent with normal estimated service life.After replacing the battery, capacitor maintenance test results 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: 24030821
• Report Number: 2017865-2026-00661
• Device Sequence Number: 12976669
• Product Code: LWS
• UDI-Device Identifier: 05414734507943
• UDI-Public: (01)05414734507943(10)4342569(17)151130
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: 11/30/2015
• Device Model Number: CD1357-40C
• Device Catalogue Number: CD1357-40C
• Device Lot Number: 4342569
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DURATA.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female