BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3211628 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08773
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 14, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 DURING A ROUTINE FOLLOW UP THIS DEVICE AND RIGHT VENTRICULAR (RV) LEAD (BOTH MODEL AND SERIAL OF THE DEVICE AND LEAD ARE UNKNOWN AT THIS TIME AS ATTEMPTS HAVE BEEN MADE TO OBTAIN) REVEALED HIGH SHOCKING IMPEDANCES GREATER THAN 200 OHMS. IN ADDITION, THE DEVICE ATTEMPTED TO DELIVER A SHOCK AND IT WAS UNKNOWN IF THE SHOCK WAS DELIVERED. THE DEVICE WAS INTERROGATED AND REPROGRAMMED FOR OPTIMIZATION. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AGENT WAS CONTACTED. THE AGENT DISCUSSED REPROGRAMMING OF THE DEVICE AND THAT THE SHOCK ENERGY WOULD STILL BE DELIVERED. IF THE PATIENT HAD INCORRECT PROGRAMMING ON THE SHOCK VECTORS THE MAY HAVE RESULTED IN A DAILY SHOCK IMPEDANCE GIVING OUT-OF-RANGE VALUES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND LEAD REMAIN IN SERVICE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311173 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F110

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening