BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR

    MDR report key: 3854601 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11492
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    April 29, 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
    IT
    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, SEVERAL EPISODES OF NON-SUSTAINED LEAD NOISE WERE OBSERVED. PROGRAMMING CHANGES WERE MADE. PATIENT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331817 ELLIPSE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2377-36C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)