BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2042477 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01179
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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 THIS DEVICE SYSTEM EXHIBITED A FLAT SHOCK MORPHOLOGY WITH NOISE PRESENT. TECHNICAL SERVICES DISCUSSED OBSERVATIONS AND RECOMMENDATIONS. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE REPORTED THAT CAPTURE COULD NOT BE VERIFIED BASED ON A SURFACE ELECTROGRAM. ADDITIONALLY, NO SENSING WAS OBSERVED. A MICRO-DISLODGMENT OF THE RIGHT VENTRICULAR (RV) LEAD WAS SUSPECTED AND A LEAD REVISION PROCEDURE WAS SCHEDULED. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED 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 73 YR 0187| E102| 0158