BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3091364 · Received April 29, 2013

    Report

    Report Number
    3091364
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT IMPLANTATION OF BOSTON SCIENTIFIC TELIGEN (100 E110) ICD THREE YEARS AGO. TODAY HE WAS AT HOME AND HE HEARD A BEEPING ALERT FROM HIS ICD. HE IMMEDIATELY NOTIFIED ME AND I ASKED HIM TO SEND A REMOTE TRANSMISSION. THIS SHOWED A WARNING FOR "VOLTAGE WAS TOO LOW FOR PROJECTED REMAINING CAPACITY" INDICATING THAT THERE WAS AN INTERNAL LEAK OF CURRENT DUE TO DEFECTIVE ICD CIRCUITRY. I NOTIFIED BOSTON SCIENTIFIC AND THEY INFORMED ME THAT THE ICD WOULD HAVE TO BE URGENTLY REPLACED IN THE NEXT 2 WEEKS BECAUSE OF THIS DEVICE MALFUNCTION. I HAVE SCHEDULED THE PATIENT FOR SURGERY ON TO CORRECT THE ISSUE. THIS DEVICE MALFUNCTION NEEDS TO BE REPORTED TO FDA.BOSTON SCIENTIFIC NOTIFIED AND THEY INFORMED ME THAT THE ICD WOULD HAVE TO BE URGENTLY REPLACED IN THE NEXT 2 WEEKS BECAUSE OF THIS DEVICE MALFUNCTION. I HAVE SCHEDULED THE PATIENT FOR SURGERY WITHIN THE NEXT FEW DAYS TO CORRECT THE ISSUE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184648 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS BOSTON SCIENTIFIC 100 E110 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *