BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE ST DR

    MDR report key: 3892651 · Received June 24, 2014

    Report

    Report Number
    2938836-2014-12366
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 28, 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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 MULTIPLE EPISODES OF NON-SUSTAINED LEAD NOISE DUE TO MYOPOTENTIAL OVERSENSING WERE OBSERVED. PROGRAMMING CHANGES WERE MADE AND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368569 ELLIPSE ST DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2277-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1