BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE ST DR, DF-4 CONNECTOR

    MDR report key: 3911050 · Received July 2, 2014

    Report

    Report Number
    2938836-2014-12988
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    May 16, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FOLLOW UP, NON-SUSTAINED LEAD NOISE DUE TO T-WAVE OVERSENSING WAS OBSERVED. THE DEVICE WAS REPROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385821 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