BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1870874 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17177
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    July 2, 2010
    Report Date
    August 23, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THESE MEDICAL DEVICES REMAIN ACTIVELY IN SERVICE WITHOUT FURTHER ISSUE. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IN ASSOCIATION WITH THE RIGHT VENTRICULAR (RV) SHOCK LEAD PORTION EXHIBITED HIGH PACE IMPEDANCE MEASUREMENT >2,000 OHMS AT IMPLANT. THE LOCAL AREA SALES REPRESENTATIVE INDICATED THAT HE DID HEAR A STRANGE CLICKING, WHICH HE ASSUMED WAS THE PHYSICIAN CROSS-THREADING THE RV P/S RESULTING IN THE OUT-OF-RANGE IMPEDANCE. THE PHYSICIAN DETERMINED TO RE-DO THE CONNECTION AND ALL WAS FINE. THE PHYSICIAN DEMONSTRATED HOW HE HAD FIRST INSERTED THE LEAD AND THEN THE WRENCH. HE HAD TURNED THE WRENCH COUNTERCLOCKWISE ONCE HE GOT THE WRENCH IN THE HEADER. THEN HE HELD THE LEAD IN THE HEADER WHILE THE ASSISTING TECHNICIAN SCREWED THE WRENCH. THE TECHNICIAN WAS NOTED AS NEW, AND IT IS POSSIBLE THAT HE TORQUED THE WRENCH AT AN ODD ANGLE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1