BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1863796 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16576
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 30, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE LEAD AND DEVICE HAVE NOT BEEN RETURNED TO BOSTON SCIENTIFIC CRM. SHOULD THE PRODUCTS BE RETURNED; THE PRODUCTS WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXPERIENCED AN INAPPROPRIATE SHOCK WHILE HOLDING AN INFANT. THE INFANT WAS SUBSEQUENTLY DROPPED AND EXPERIENCED A SKULL FRACTURE THAT REQUIRED SURGERY. THE INFANT HAS RECOVERED. UPON INTERROGATION OF THE DEVICE, IT WAS NOTED THAT THE INAPPROPRIATE SHOCK WAS LIKELY DUE TO OVERSENSING AS A RESULT OF A RIGHT VENTRICULAR DEFIBRILLATION LEAD FRACTURE WITH IMPEDANCES GREATER THAN 2000 OHMS. IT WAS ALSO NOTED THAT THE LEAD HAD INCREASED THRESHOLDS. A REVISION PROCEDURE WAS PERFORMED; THE LEAD AND DEVICE WERE REMOVED. THE PRODUCTS REMAIN WITH THE PATIENT AND WERE NOT RETURNED AT THIS TIME.

    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 Life Threatening| R