BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF DR

    MDR report key: 3781729 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-09921
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    February 6, 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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: THE REPORTED FIELD EVENT OF RESET WAS CONFIRMED IN THE LABORATORY. UPON RECEIPT, THE DEVICE WAS INTERROGATED AND FOUND IN BACKUP DFO. REVIEW OF THE DEVICE IMAGE INDICATED THAT THE DEVICE ENTERED RESET AFTER CHARGING DURING TELEMETRY CAUSING TELEMETRY ERRORS. THE DEVICE WAS TESTED ON THE BENCH AS WELL AS USING AUTOMATED TEST EQUIPMENT, AND NO ANOMALY WAS FOUND. THE CAUSE OF THE BACKUP DFO WAS CHARGING DURING TELEMETRY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE SHOCKS AND ATP THERAPY. DURING INTERROGATION, DEVICE WAS FOUND IN BACKUP VVI MODE. DEVICE WAS EXPLANTED AFTER INTERROGATION AND PROGRAMMING WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260105 CURRENT RF DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD 2207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention