BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT VR RF

    MDR report key: 3910989 · Received July 2, 2014

    Report

    Report Number
    2938836-2014-12979
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    May 27, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE REPORTED BACKUP VVI WAS NOT CONFIRMED IN THE LABORATORY. THE DEVICE WAS NOT IN BACKUP VVI MODE UPON RECEIPT. REVIEW OF THE DEVICE IMAGE INDICATED A FIRMWARE DOWNLOAD WAS PERFORMED IN THE FIELD WHICH CLEARED THE ORIGINAL DATA REGARDING THE RESET. THE CAUSE OF THE RESET COULD NOT BE DETERMINED. THE REPORTED OUTPUT ANOMALY WAS CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND THE HIGH VOLTAGE OUTPUT CIRCUITRY WAS FOUND TO BE DAMAGED. THE CAUSE OF THE CIRCUIT DAMAGE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED TO THE HOSPITAL FOR LEAD REPLACEMENT. DEVICE WAS OBSERVED IN BACKUP VVI. THE DEVICE WAS EXPOSED TO ELECTROSURGERY. THE NEXT DAY AN ALERT FOR POSSIBLE OUTPUT CIRCUIT DAMAGE WAS OBSERVED. ABORTED CHARGES DUE TO SHORTED OUTPUT STAGE DETECTION WERE NOTED. NO OTHER ELECTRICAL ANOMALIES WERE DETECTED. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386496 CURRENT VR RF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD 1207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention