BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE ST VR, DF-4 CONNECTOR

    MDR report key: 3914531 · Received July 3, 2014

    Report

    Report Number
    2938836-2014-13118
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 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
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXHIBITED FAR P-WAVE OVERSENSING. RECOMMENDED PROGRAM CHANGES WERE MADE AND NO FURTHER ISSUES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390365 ELLIPSE ST VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1277-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 BSX LEAD 0293, 107946