BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2170371 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09667
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) PATIENT SERVICES SUGGESTED THE PATIENT SEEK MEDICAL ADVICE AS SOON AS POSSIBLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT CALLED LATITUDE PATIENT SERVICES TO INQUIRE ABOUT WHETHER OR NOT HE HAD BEEN SHOCKED. THE PATIENT WAS FOUND LAYING ON THE FLOOR BY A PATIENT ADVOCATE AND WAS UNSURE IF THAT WAS DUE TO A SHOCK OR NOT.

    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 41 YR Life Threatening 4136| E110| 0185