MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY ASSURA VR ICD_IDE_US; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	CD1257-40Q
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented remotely via merlin.Net.Upon review, it was found that patient's implantable cardioverter defibrillator (icd) was in backup mode due to hardware reset.Loss of defibrillation therapy was also noted due to backup.No intervention was performed.The patient was stable.
Event or Problem Description
New information received notes that the implantable cardioverter defibrillator (icd) was explanted and replaced.The patient was stable after procedure.
Additional Manufacturer Narrative
Premature battery depletion and backup operation was confirmed by analysis.The backup operation was due to low battery voltage; the low battery voltage was a result of premature battery depletion.A device evaluation was performed, and no sources of high current were noted.The cause of the premature battery depletion was consistent with li cluster formation.From these analyses, in the absence of high current draw, it is probable that the premature battery depletion was caused by a lithium cluster induced short circuit.Li clusters are a known depletion mechanism for these advisory products that has been investigated and associated with a field action in october 2016.

• Brand Name: FORTIFY ASSURA VR ICD_IDE_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: 17201498
• Report Number: 2017865-2023-24250
• Device Sequence Number: 17828071
• Product Code: NVZ
• UDI-Device Identifier: 05414734505475
• UDI-Public: 05414734505475
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/07/2023

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: 07/31/2015
• Device Model Number: CD1257-40Q
• Device Catalogue Number: CD1257-40Q
• Device Lot Number: 4418334
• 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: 06/08/2023
• Supplement Date Received by Manufacturer: 06/30/2023; 09/01/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 07/18/2023; 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0115-2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OPTISURE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male