BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1953829 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24402
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS SYSTEM WAS EXPLANTED DUE TO TWIDDLERS SYNDROME. 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 E102

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR 0184| E102| 0180