BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPL LEAD, TRANSVENOUS

    MDR report key: 1831069 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03623
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    July 9, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP950022
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 THE HV LEAD IMPEDANCE HAD DECREASED. THE PHYSICIAN ELECTED TO LEAVE THE LEAD IN PLACE AND MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPL LEAD, TRANSVENOUS DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION SP02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR