BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSE VR, DF-4 CONNECTOR

    MDR report key: 4627143 · Received March 24, 2015

    Report

    Report Number
    2938836-2015-02967
    Event Type
    Injury
    Date Received
    March 24, 2015
    Date of Event
    February 10, 2015
    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
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI (DI): (B)(4). THE REPORTED HIGH DFT WAS NOT CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AS WELL AS USING AUTOMATED TEST EQUIPMENT, AND NO ANOMALY WAS FOUND. THE REPORTED OUTPUT ANOMALY ALERT WAS CONFIRMED IN THE LABORATORY AND WAS BELIEVED TO BE CAUSED BY APPLICATION OF EXTERNAL DEFIBRILLATION DURING DFT TESTING. THE DEVICE WAS TESTED ON THE BENCH AS WELL AS USING AUTOMATED TEST EQUIPMENT, AND NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HV THERAPY WAS UNABLE TO CONVERT VENTRICULAR FIBRILLATION DURING A DFT TEST. EXTERNAL DEFIBRILLATION WAS USED TO RESCUE THE PATIENT. PROGRAMMING CHANGES WERE MADE AND A VENTRICULAR FIBRILLATION WAS INDUCED, BUT THE HV THERAPY WAS STILL UNABLE TO CONVERT THE RHYTHM AND EXTERNAL DEFIBRILLATION WAS USED TO RESCUE THE PATIENT AGAIN. AN ALERT FOR POSSIBLE HV OUTPUT CIRCUIT DAMAGE WAS THEN OBSERVED. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE DEVICE. THE PATIENT WAS IN GOOD CONDITION AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197887 ELLIPSE VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1377-36QC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention