BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1873955 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17826
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 1, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN REVIEWING THE DEVICE'S ARRHYTHMIA LOGBOOK, TECHNICAL SERVICES FOUND NO NEW EPISODES TO INDICATE THAT THE PATIENT WAS IN AN ARRHYTHMIA PRIOR TO EXPERIENCING PEA. NO CHANGE IN PACING THRESHOLDS WAS NOTED, AND NO SIGN OF A DEVICE MALFUNCTION WAS FOUND. THE BOSTON SCIENTIFIC TECHNICAL SERVICES DEPARTMENT ADVISED THAT DEVICE FUNCTION APPEARED TO BE NORMAL, AND THAT A CHANGE IN PATIENT CONDITION MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. AN ATTEMPT HAS BEEN MADE TO GATHER ADDITIONAL INFORMATION. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT WAS ADMITTED TO THE HOSPITAL AFTER EXPERIENCING PULSELESS ELECTRICAL ACTIVITY (PEA). THE PATIENT WAS REPORTEDLY BEING PACED BY THE DEVICE DURING THIS TIME. A PHYSICIAN REQUESTED THE ASSISTANCE OF THE BOSTON SCIENTIFIC TECHNICAL SERVICES DEPARTMENT IN VERIFYING THAT NO LOSS OF CAPTURE OCCURRED, AND IN REVIEWING ANY STORED EVENTS THAT MAY HAVE BEEN RECORDED PRIOR TO THE PEA.

    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 86 YR Hospitalization| L A155| 4087| 0185| E110