BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2780056 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-11997
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    August 26, 2012
    Report Date
    September 1, 2012
    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

    RESOLUTION HAS BEEN REQUESTED FROM THE FIELD, HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS EVENT WILL BE UPDATED UPON FURTHER INFORMATION PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED A LOW SHOCK IMPEDANCE OF LESS THAN 20 OHMS. 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 68 YR 4470| 0158| H177| E110