BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1953550 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-23886
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 9, 2010
    Report Date
    March 25, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    APPROXIMATELY 3.5 MONTHS LATER, THE PATIENT PRESENTED TO AN EMERGENCY ROOM AFTER RECEIVING SEVERAL SHOCKS AND WAS EXTERNALLY RESCUED AT SOME POINT. DEVICE INTERROGATION SHOWED A FAULT CODE FOR AN OPEN ELECTRICAL CIRCUIT AND A HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT RECORDED DURING ONE OF THE SHOCK-DELIVERY EPISODES. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) ADVISED THAT THE LEAD LIKELY WAS FRACTURED AND THAT THE DEVICE MAY NOT BE ABLE TO DELIVER SHOCK ENERGY TO THE PATIENT'S HEART.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE AND ANOTHER MANUFACTURER'S RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WERE ASSOCIATED WITH A REMOTE MONITORING ALERT FOR A HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT. 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 77 YR Hospitalization| R (B)(4)| (B)(4)