BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST JUDE MEDICAL

    MDR report key: 2400893 · Received January 2, 2012

    Report

    Report Number
    MW5023686
    Event Type
    Malfunction
    Date Received
    January 2, 2012
    Date of Event
    December 28, 2011
    Report Date
    January 2, 2012
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PERFORMED AN HV LEAD IMPEDANCE CHECK ON SJM V-168-ATLAS II VR DEVICE. IN THE PROCESS OF CHECKING THIS VALUE, THE WAND MOVED OFF THE DEVICE. ONCE THE WAND WAS REPOSITIONED, THE DEVICE DELIVERED THE REQUIRED SHOCK TO CHECK THE IMPEDANCE BUT WE WERE UNABLE TO OBTAIN THE READING OF THE VALUE. TECHNICAL SUPPORT FROM SJM CAN NOT EXPLAIN WHY WE CAN NOT OBTAIN THE VALUE EVEN AFTER SHUTTING DOWN THE PROGRAMMER AND RE-INTERROGATING THE DEVICE. REASON FOR USE: VENTRICULAR TACHYCARDIA AND CARDIOMYOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL ATLAS II LWS V-168

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR