BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2010-23072

    MDR report key: 1951517 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23072
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION AS TO THESE PRODUCTS IS NOT KNOWN. THE INVESTIGATION IS CONSIDERED CLOSED DUE TO THE LACK OF ACCESSIBLE INFORMATION AT THIS TIME. 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IN ASSOCIATION WITH THE TRANSVENOUS RIGHT ATRIAL (RA) LEAD DID EXHIBIT GREATER THAN 2,000 OHMS PACE IMPEDANCE MEASUREMENT. THE LOCAL AREA SALES REPRESENTATIVE ATTEMPTED TO GET MORE INFORMATION AS TO THE MODEL AND SERIAL NUMBER INFORMATION FOR THE RELATED DEVICES, BUT WAS NOT SUCCESSFUL. THERE WAS NO REPORT OF ADVERSE PATIENT SYMPTOM OR SURGICAL INTERVENTION ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    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