BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3213029 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09336
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 5, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EFFORTS TO OBTAIN ADDITIONAL DETAILS REGARDING THE REPORTED CLINICAL OBSERVATIONS WERE UNSUCCESSFUL. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT STATED SHE HAS BEEN PASSING OUT FOR THREE WEEKS. THE PATIENT WAS INQUIRING ABOUT WHERE THIS INFORMATION GOES AND HOW IT GETS TO HER PHYSICIAN AS SHE DOES NOT HAVE HER COMMUNICATOR PLUGGED IN ALL THE TIME. A PATIENT SERVICES CONSULTANT INFORMED THE CALLER THAT THE INFORMATION GOES TO HER DOCTOR AND CLINIC AND STATED THAT THE LATEST SEND WAS LAST WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312608 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening 4086| T165| E110| 0184