BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT DR RF

    MDR report key: 4021786 · Received August 19, 2014

    Report

    Report Number
    2938836-2014-14554
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    June 30, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. POST-SENSED T-WAVE OVERSENSING WAS OBSERVED ON STORED EGM. THE DEVICE WAS REPROGRAMMED AND REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499406 CURRENT DR RF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD 2207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR