BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2080315 · Received May 6, 2011

    Report

    Report Number
    2124215-2011-08049
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 4, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TERMINAL PIN WAS RECONNECTED IN THE HEADER AND BOTH PRODUCTS REMAIN IMPLANTED AND IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. 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 DURING A NORMAL PATIENT FOLLOW UP, IT WAS DISCOVERED THAT THE SHOCK IMPEDANCE MEASUREMENT FOR THIS RIGHT VENTRICULAR (RV) LEAD WAS ABOVE 125 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A LEAD REVISION WAS PERFORMED AND IT WAS DISCOVERED THAT ONE OF THE DEFIBRILLATION TERMINAL PINS WAS NOT COMPLETELY SECURED IN THE HEADER OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 0165