BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR

    MDR report key: 3873019 · Received June 13, 2014

    Report

    Report Number
    2938836-2014-11882
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    April 24, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED EXTENDED CHARGE TIME WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF THE DEVICE IMAGE. THE HV CAPACITORS WERE SENT TO THE MANUFACTURING SITE FOR FURTHER EVALUATION AND AN ANOMALOUS CAPACITOR WAS FOUND. THE ROOT CAUSE OF THE EXTENDED CHARGE TIME WAS AN ANOMALOUS CAPACITOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CAPACITOR MAINTENANCE TIMEOUT OCCURRED IN THE DEVICE WHILE STILL IN THE BOX. THE DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350138 ELLIPSE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2411-36C NA

    Patients

    Seq Age Sex Outcome Treatment
    1