BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3971347 · Received July 31, 2014

    Report

    Report Number
    2124215-2014-14800
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 23, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 DEVICE SETTINGS FOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOWED THE DEVICE WAS IN MONITOR+THERAPY, HOWEVER IS LISTED AS STORAGE MODE UNDER LAST PROGRAMMING WITH A DATE FROM A COUPLE YEARS EARLIER. A SAVE TO DISK WAS SENT FOR ANALYSIS WHICH FOUND A MEMORY ERROR IN THE CHANGE LOG. THERAPY IS NOT EFFECTED AS THE CHANGE LOG IS DIAGNOSTIC. THE DEVICE IS IN THE CORRECT TACHY MODE FOR DETECTION. TROUBLESHOOTING STEPS WERE PROVIDED TO CORRECT THE ERROR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446722 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR 1861| 4087| 0155| T165| E110