BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TVL ADX

    MDR report key: 4210758 · Received October 29, 2014

    Report

    Report Number
    2938836-2014-17217
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 16, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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 THE LEAD EXHIBITED LOW, OUT OF RANGE PACING LEAD IMPEDANCE. LEAD REMAINS IMPLANTED AND WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692999 TVL ADX DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1559/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR