BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM

    MDR report key: 2172868 · Received July 22, 2011

    Report

    Report Number
    2124215-2011-10256
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    KRG
    PMA / PMN Number
    P910077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN RV THRESHOLD TEST WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND ZOOM LATITUDE PROGRAMMER THERE WERE TELEMETRY PROBLEMS EXPERIENCED FOLLOWING LOSS OF CAPTURE. THE THRESHOLD TEST WAS NOT ENDED RIGHT AWAY AND THE PATIENT EXPERIENCED ASYSTOLE FOR APPROXIMATELY 6 SECONDS. IT WAS BELIEVED THAT WANDED TELEMETRY WAS BEING USED. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED TELEMETRY PRIORITY AND THAT UNLESS WIRELESS WAS TURNED OFF (EITHER FOR THIS SESSION OR FOR ON THE PROGRAMMER FOR ALL SESSIONS) THAT IT WOULD TRUMP THE WANDED TELEMETRY, UNLESS WIRELESS TELEMETRY WENT COMPLETELY OUT. THE TIME FOR THE COMMUNICATION TO SWITCH OVER TO WANDED TELEMETRY WAS UNKNOWN, AS IT WOULD VARY BASED ON IF YOU THERE WAS INTERMITTENT WIRELESS TELEMETRY OR IF IT COMPLETELY DROPPED OUT. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOOM KRG GUIDANT PUERTO RICO BV 3120

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR E110| 4470| N119| 0181| 4195