BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA ST DR

    MDR report key: 4210692 · Received October 29, 2014

    Report

    Report Number
    2938836-2014-17234
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    August 28, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF THE DEVICE IMAGE AND WAS DUE TO HIGH CURRENT DRAIN. THE CAUSE OF THE HIGH CURRENT DRAIN WAS AN ANOMALOUS COMPONENT ON THE HYBRID.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC FOR A ROUTINE FOLLOW-UP. DEVICE INTERROGATION INDICATED THAT THE BATTERY HAD 1.2 YEARS REMAINING LONGEVITY WITH HIGH CURRENT DRAIN. DEVICE WAS EXPLANTED DUE TO RAPID BATTERY DEPLETION. PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692874 FORTIFY ASSURA ST DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2359-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention