BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSE VR, DF-4 CONNECTOR

    MDR report key: 4220998 · Received November 3, 2014

    Report

    Report Number
    2938836-2014-17416
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    April 8, 2013
    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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE REPORTED EXTENDED CHARGE TIME ANOMALY WAS CONFIRMED IN THE LABORATORY. THE HV CAPACITORS WERE RETURNED TO THE MANUFACTURER FOR FURTHER ANALYSIS AND AN INTERNAL CAPACITOR ANOMALY WAS FOUND TO BE THE CAUSE OF THE EXTENDED CHARGE TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE PATIENT PRESENTED IN CLINIC, AN EXTENDED CHARGE TIME ALERT WAS ISSUED AFTER AN IN-CLINIC CAPACITOR MAINTENANCE. A POP SOUND WAS HEARD DURING THE CHARGE. THE DISPLAYED MESSAGE INDICATED THE LONG CHARGE TIME OCCURRED IN 2013, PRIOR TO IMPLANT, DURING THE MANUFACTURING PERIOD. A SECOND CAPACITOR MAINTENANCE RESULTED IN A NORMAL CHARGE TIME. THE DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702231 ELLIPSE VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1311-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention