BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA DR ICD, US

    MDR report key: 8663085 · Received June 3, 2019

    Report

    Report Number
    2017865-2019-09012
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    May 20, 2019
    Report Date
    December 21, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVZ
    UDI-DI
    05414734508094
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMUNICATION FAILURE AND PREMATURE BATTERY DEPLETION WERE CONFIRMED BY ANALYSIS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED IN CLINIC AFTER IT WAS FOUND THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD NOT BEEN ABLE TO BE COMMUNICATED WITH REMOTELY. THE DEVICE WAS SUBJECT TO THE RAPID BATTERY DEVICE ADVISORY, BUT NO BATTERY PERFORMANCE ALERT (BPA) HAD BEEN RECEIVED. THE BPA DEVICE FIRMWARE UPGRADE HAD NOT BEEN APPLIED TO THIS DEVICE. MULTIPLE ATTEMPTS TO COMMUNICATE WITH THE DEVICE WERE UNSUCCESSFUL. UPON CALL WITH TECHNICAL SERVICES, THE LOSS OF TELEMETRY COINCIDED WITH RAPID BATTERY DEPLETION BEHAVIOR. DEVICE REPLACEMENT WAS RECOMMENDED BUT NOT SCHEDULED. THERE WERE NO OUT OF THE ORDINARY SYMPTOMS OR ADVERSE EVENTS.

    Description of Event or Problem · 1

    NEW INFORMANTION NOTES THAT THE DEVICE WAS EXPLANTED AND REPLACED. PATIENT WAS STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457016 FORTIFY ASSURA DR ICD, US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NVZ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD2357-40Q 4512279 05414734508094

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention