BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 4131775 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14024
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 14, 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 SYSTEM DETECTED A FAULT CODE, INDICATING VOLTAGE TOO LOW FOR REMAINING PROJECTED LONGEVITY. DEVICE DATA WAS SAVED TO A DISK FOR FURTHER EVALUATION. EVALUATION OF THE DATA CONFIRMED THE PRESENCE OF THE FAULT CODE, HOWEVER, INDICATED THAT THERAPY DELIVER WAS UNAFFECTED. IT WAS RECOMMENDED THAT THE DEVICE BE EXPLANTED AND RETURNED FOR RELIABILITY ANALYSIS, HOWEVER, THE DATA INDICATED WITH A HIGH LIKELIHOOD THAT THERE WAS SUFFICIENT RESERVE FOR THE DEVICE TO MAINTAIN NORMAL THERAPY FUNCTIONS FOR 28 DAYS TIME. THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT WITH THIS DEVICE SYSTEM WAS TERMINALLY ILL FOR AN UNRELATED REASON AND THERE WAS NO PLAN TO REPLACE THE DEVICE. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612223 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR E110| 0180| 4470