BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSE ST DR, DF-4 CONNECTOR

    MDR report key: 4220929 · Received November 3, 2014

    Report

    Report Number
    2938836-2014-17456
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    June 30, 2014
    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
    SE
    Reporter Occupation
    PHYSICIAN

    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 RETURNED TO THE MANUFACTURER FOR EVALUATION AND AN ANOMALOUS HV CAPACITOR WAS FOUND TO BE THE CAUSE OF THE EXTENDED CHARGE TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALERTS FOR CHARGE TIME LIMIT REACHED WERE OBSERVED. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703604 ELLIPSE ST DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2277-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention