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

Model Number	CD1257-40Q
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is included in the battery performance alert advisory issued by abbott on 28 august 2017.
Event or Problem Description
Following the battery performance alert (bpa) advisory, a bpa was received by the clinician and awaiting explant.Further information was requested, but not yet available.Further information was requested, however was not provided.
Event or Problem Description
New information noted that the device was explanted and replaced.The patient was stable post procedure.
Additional Manufacturer Narrative
Premature battery depletion was confirmed by analysis.A device evaluation was performed, and no sources of high currents were noted.The cause of the premature battery depletion was consistent with li cluster formation.From these analyses, in the absence of a 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 have been investigated and associated with a field action in october 2016.

• Brand Name: FORTIFY ASSURA VR ICD_IDE_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: 16211801
• Report Number: 2017865-2023-02653
• Device Sequence Number: 14566410
• Product Code: NVZ
• UDI-Device Identifier: 05414734505475
• UDI-Public: 05414734505475
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2023

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: 10/31/2013
• Device Model Number: CD1257-40Q
• Device Catalogue Number: CD1257-40Q
• Device Lot Number: 3696911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2022
• Supplement Date Received by Manufacturer: 01/19/2023; 03/02/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 02/08/2023; 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2012
• 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-0003-2018;Z-0115-2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male