BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3211138 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09696
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    March 15, 2013
    Report Date
    April 24, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    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 THIS PATIENT'S HOME MONITORING SYSTEM DETECTED THAT THE DEVICE HAD BEEN PROGRAMMED TO TACHY THERAPY OFF AT SOME POINT. ATTEMPTS TO DETERMINE WHY HAVE BEEN MADE AND NO INFORMATION IS AVAILABLE AT THIS TIME. THE PATIENT PREVIOUSLY WAS SEEN IN CLINIC AND THE HEALTH CARE PROFESSIONAL (HCP) WAS QUESTIONING WHY THE ELECTROGRAM (EGM) DIDN'T ALWAYS SHOW THE ATRIAL EVENTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AT THAT TIME AND SUGGESTED SOME PROGRAMMING CHANGES TO ALLEVIATE THE ISSUE. IT IS UNKNOWN IF ANY PROGRAMMING CHANGES WERE MADE. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310353 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR 5076| 7278| 6947| E110