BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2011-07237

    MDR report key: 2162576 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07237
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN AS TO WHETHER THIS LEAD HAD BEEN REMOVED FROM SERVICE OR WHETHER THERE HAD BEEN ANY PATIENT ADVERSE SYMPTOM OR IMPACT ON CRITICAL THERAPY. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD WAS SUSPECTED AS BEING FRACTURED. THE ASSOCIATED PATIENT WAS BEING IMPLANTED WITH A NON-BSC DEVICE AT THE TIME OF THIS EVENTED INFORMATION. THE DEVICE SYSTEM WAS BEING INTERROGATED AT WHICH TIME, SHOCK IMPEDANCE WAS OBSERVED AS GREATER THAN 200 OHMS IN ALL VECTORS. THE PATIENT WAS FROM OUTSIDE THE UNITED STATES BUT BEING IMPLANTED IN THE UNITED STATES. THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT SEARCHED EVERY AVAILABLE RECORD SOURCE BUT COULD NOT LOCATE THE PATIENT IN THE BOSTON SCIENTIFIC MEDICAL RECORDS SYSTEM, NOR BY CALLING THE NON-BSC TECHNICAL SERVICES. RV PACING IMPEDANCE REMAINED WITHIN NORMAL LIMITS, AS WAS THE FARFIELD ELECTROCARDIOGRAM FROM RV COIL TO DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LWS GUIDANT PUERTO RICO BV TACHY DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention