BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2051830 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03369
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 22, 2011
    Report Date
    August 12, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE PRODUCT WAS PERFORMED. THE DEVICE HAD NO TELEMETRY UPON RETURN. THE DEVICE CASE WAS OPENED. AN EXTERNAL POWER SUPPLY WAS CONNECTED TO THE DEVICE AND THE ELECTRICAL CURRENT WAS MONITORED. DURING THE MONITORING PROCESS A HIGH CURRENT CONDITION WAS OBSERVED. ELECTRICAL TESTING AND ANALYSIS WERE THEN CONDUCTED, WHICH ISOLATED THE HIGH CURRENT TO AN ANOMALY ON ONE OF THE COMPONENT LAYERS (GATE OXIDE) WITHIN AN INTEGRATED CIRCUIT. THIS ANOMALY CAUSES A HIGH CURRENT DRAIN, WHICH OVER TIME RESULTED IN THE REPORTED CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT AS A RESULT OF NEVER BEING ABLE TO COMMUNICATE OR OBTAIN TELEMETRY, THIS DEVICE WAS EXPLANTED AND REPLACED. ONCE THE DEVICE WAS EXPLANTED, TELEMETRY WAS NOT ACHIEVED.

    Description of Event or Problem · 1

    THE PATIENT WAS BROUGHT INTO THE CLINIC AND THE DEVICE WAS UNABLE TO BE INTERROGATED WHEN USING MULTIPLE PROGRAMMERS. THE RF ANTENNA ON THE DEVICE WAS OBSERVED TO BE POINTED INWARD. TECHNICAL SERVICES DISCUSSED RECOMMENDATIONS TO INTERROGATE THE DEVICE. A MAGNET WAS PLACED OVER THE DEVICE, HOWEVER, NO TONES WERE PRODUCED. IT WAS NOTED THAT THE PATIENT IMPLANTED WITH THIS DEVICE WAS LARGE BREASTED AND THE DEVICE HAD POSSIBLY MIGRATED. AN XRAY OF THE DEVICE DISPLAYED THAT THE LEADS WERE TWISTED AND THE DEVICE HAD MIGRATED. THE PATIENT'S PHYSICIAN SENT THE PATIENT HOME TO INTERROGATE VIA THE LATITUDE HOME MONITORING SYSTEM, HOWEVER, THE DEVICE WAS NOT ABLE TO BE INTERROGATED VIA LATITUDE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS UNABLE TO BE INTERROGATED. THE PATIENT WAS TO BE BROUGHT IN FOR FURTHER EVALUATION IN ONE WEEK. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R E110| T165| 4479| 0184