BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3212569 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08258
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 16, 2013
    Report Date
    August 14, 2013
    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

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    Additional Manufacturer Narrative · 1

    AT THIS TIME THE DEVICE REMAINS IN SERVICE. A FINAL REPORT WILL BE SENT AFTER INFORMATION IS RECEIVED OF THE DEVICE MODEL AND SERIAL NUMBER ALONG WITH THE DATA DISK ANALYSIS FROM THE BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ENGINEER. IF THE A REVISION IS PERFORMED, AND THE PRODUCT IS RETURNED TO BOSTON SCIENTIFIC LABORATORY ANALYSIS WILL BE PERFORMED IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (MODEL AND SERIAL NUMBER ARE UNKNOWN AT THIS TIME) HAD TRIGGERED A FAULT CODE 1003 WHICH OCCURRED DUE TO AN OUT OF RANGE VOLTAGE MEASUREMENT ON THE DEVICE WHICH WAS TOO LOW FOR PROJECTED LONGEVITY. THE LOW VOLTAGE MEASUREMENT WAS REVIEWED AND ALL OTHER MEASUREMENTS WERE CONFIRMED STABLE AT THIS TIME. THE PHYSICIAN IS ARE OF THE SITUATION AND A DATA DISK HAS BEEN SENT INTO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR REVIEW OF THE FAULT CODE. THE DEVICE REMAINS IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313384 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F110

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening