BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 4220938 · Received November 3, 2014

    Report

    Report Number
    2124215-2014-17612
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WAS IN THE EMERGENCY ROOM (ER) AND WAS REQUESTING TO HAVE THE DEVICE INTERROGATED. BOSTON SCIENTIFIC TECHNICAL SERVICES WAS CONTACTED FOR ASSISTANCE WITH PAGING A BOSTON SCIENTIFIC FIELD REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT WAS HAVE PROBLEMS WITH THEIR DEVICE. ADDITIONAL INFORMATION WAS SOUGHT FROM THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE. THE REPRESENTATIVE STATED THAT THE HOSPITAL PERFORMED THE CHECK. WHILE IN THE ER, NO ADVERSE PATIENT EFFECTS WERE REPORTED. THERE HAVE BEEN NO ADDITIONAL ISSUES OR INFORMATION REPORTED REGARDING THIS EVENT. THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703607 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening 0147| E110| 1861| 4087| 4470