BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF DR

    MDR report key: 3781748 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-09890
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 17, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    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 BACKUP VVI WAS CONFIRMED IN THE LABORATORY. REVIEW OF THE DEVICE IMAGE INDICATED THAT THE DEVICE WENT INTO BACKUP VVI DUE TO A POWER-ON RESET DURING HV THERAPY DELIVERY. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT, AND NO ANOMALY WAS FOUND. THE CAUSE OF THE POWER-ON RESET COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALERT TRANSMISSION WAS RECEIVED IN THE CLINIC SHOWING THE DEVICE IN BACK UP VVI. SUBSEQUENTLY DURING AN IN CLINIC VISIT, INTERROGATION CONFIRMED THE DEVICE WAS IN BACK UP VVI. THE DEVICE WAS EXPLANTED AND REPLACED. PATIENT HAD NO ISSUES AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260726 CURRENT RF DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD 2207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention