BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSE DR, DF-4 CONNECTOR

    MDR report key: 4220928 · Received November 3, 2014

    Report

    Report Number
    2938836-2014-17451
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    July 13, 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
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.THE REPORTED EXTENDED CHARGE TIME WAS CONFIRMED IN THE LABORATORY. THE HV CAPACITORS WERE SENT 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 THAT VIA REMOTE TRANSMISSION, MULTIPLE CHARGE TIME LIMIT REACHED ALERTS WERE OBSERVED. IN-CLINIC CAPACITOR MAINTENANCE WAS PERFORMED WHICH RESULTED IN A LONG CHARGE TIME. DEVICE WAS EXPLANTED AND REPLACED. PATIENT CONDITION WAS STABLE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703464 ELLIPSE DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2311-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention