BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE VR

    MDR report key: 4031717 · Received August 22, 2014

    Report

    Report Number
    2938836-2014-14752
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Date of Event
    July 10, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF EXTENDED CHARGE TIME WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF THE DEVICE IMAGE. THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE FOUND. THE HV CAPACITORS WERE SENT TO THE MANUFACTURING SITE FOR FURTHER EVALUATION AND AN ANOMALOUS CAPACITOR WAS FOUND. THE CAUSE OF THE EXTENDED CHARGE TIME WAS AN ANOMALOUS HV CAPACITOR.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO IMPLANT, A LONG CHARGE TIME ALERT WAS OBSERVED WHILE THE DEVICE WAS STILL IN THE BOX. MULTIPLE MANUAL CAPACITOR MAINTENANCES WERE UNSUCCESSFUL. THE DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509020 ELLIPSE VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1411-36C NA

    Patients

    Seq Age Sex Outcome Treatment
    1