BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2163439 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07326
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED HIGH SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS AND INCREASED THRESHOLD MEASUREMENTS OF 2.5 VOLTS. TECHNICAL SERVICES (TS) SUGGESTED PERFORMING LOW AND MAXIMUM ENERGY SHOCKS TO CHECK THE LEAD CONNECTION. ADDITIONAL INFORMATION INDICATED AN XRAY WAS NOT PERFORMED. THE DEVICE WAS REPROGRAMMED TO TAKE THE PROXIMAL COIL OUT OF THE CONFIGURATION WHICH RESULTED IN NORMAL IMPEDANCES. THE FIELD REPRESENTATIVE SUSPECTS THE ISSUE TO BE WITH THE PROXIMAL PORT SETSCREW. HE INDICATED THAT DFT'S WOULD BE PERFORMED TO TEST THE NEW PROGRAMMING. IF IT DID NOT WORK, A REVISION WOULD BE SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR (B)(4)| (B)(4)| (B)(4)