BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2910790 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16589
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 17, 2012
    Report Date
    November 17, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC FIELD REPRESENTATIVE PERFORMED A DEVICE INTERROGATION AND PROVIDED THE DEVICE INFORMATION TO THIS PATIENT'S PHYSICIAN. THE CLINICAL OBSERVATIONS HAVE BEEN DOCUMENTED AND 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 RECEIVED A SHOCK FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) AND EXPERIENCED A SYNCOPAL EVENT. THE CALLER WAS REQUESTING A BOSTON SCIENTIFIC REPRESENTATIVE TO COME INTERROGATE THE DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18342 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R 0154| 1861| E110| 4086