BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1950958 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23079
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A PATIENT IMPLANTED WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRESENTED TO THE HOSPITAL AFTER HAVING HAD TWO SYNCOPAL EPISODES. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND IT WAS NOTED THEY WERE DEFIBRILLATED FOUR TIMES BEFORE THE PHYSICIAN COULD GET THE ICD "FUNCTIONAL". IT WAS ALSO NOTED THAT THE PATIENT'S INITIAL ELECTROCARDIOGRAM SHOWED THE PATIENT HAD LONG QT SYNDROME, WHICH IMPROVED WITH MEDICATION CHANGES. THE DEVICE WAS ALSO REPROGRAMMED WHICH WAS NOTED TO HAVE SUPPRESSED THE PATIENT'S ECTOPY. THE PATIENT THEN GOT SHOCKED AGAIN FOR VENTRICULAR FIBRILLATION (VF) AND THEY SUBSEQUENTLY HAD AN ABLATION, WHICH DID NOT RESOLVE THE PATIENT'S ECTOPY. IT WAS QUESTIONED HOW TO PROGRAM THE DEVICE.

    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 Life Threatening