BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1945854 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-22076
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUCCESSFULLY INTERROGATED BY BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY. THE DEVICE WAS PUT THROUGH AND PASSED A SERIES OF AUTOMATED DIAGNOSTIC TESTS THAT VERIFY DEVICE FUNCTIONALITY COMMENSURATE WITH BATTERY STATUS. IT WAS CONCLUDED THAT THE DEVICE PERFORMED NORMALLY THROUGHOUT LABORATORY TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM AN IMPLANT FORM THAT THIS DEVICE WAS ELECTIVELY EXPLANTED DUE TO ADVISORY/RECALL. THERE WAS NO REPORTED OR OBSERVED MALFUNCTION OF THE DEVICE. THERE WAS NO VISIBLE SIGN OF WEAKNESS IN HEADER BOND AND THE DECISION TO REPLACE WAS PREVENTATIVE. THE PATIENT'S HISTORY IS REMARKABLE FOR DEVICE MIGRATION WITHIN THE POCKET SO AS TO VISIBLY AND PHYSICIALLY PROTRUDE FROM THE SKIN.

    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 56 YR Hospitalization| L| R 1861| 0157| 5076| E110