BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3053316 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05594
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 12, 2013
    Report Date
    April 18, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THIS DEVICE WAS THOROUGHLY ANALYZED IN OUR QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THE CLINICAL OBSERVATION OF A WEAKENED HEADER BOND. X-RAY EXAMINATION WAS PERFORMED. THE HEADER WIRE WAS FOUND TO BE FRACTURED. THE BATTERY VOLTAGE WAS CONFIRMED TO BE LOW AND A REVIEW OF DEVICE MEMORY NOTED THAT THE DEVICE EXPERIENCED MULTIPLE FAULTS ON (B)(6) 2013. MICROSCOPIC VISUAL INSPECTION FOUND THAT THE HEADER WAS LOOSE, AND AN X-RAY CONFIRMED THAT THE DF- FEEDTHROUGH WIRE WAS CRACKED. SOME FRAGMENTS WERE ALSO NOTED INSIDE THE DEVICE CASE. WHEN THE HEADER WAS REMOVED, ONE OF THE ANCHOR POSTS STAYED INSIDE THE HEADER, RATHER THAN REMAINING ON THE CASE AS EXPECTED. THE DEVICE CASE WAS ALSO REMOVED AND FLUID WAS NOTED INSIDE THE CASE, AND BODY FLUID CONTAMINATION WAS PRESENT IN THE ANCHOR POST HOLD. THE LOOSE HEADER RESULTED IN THE BROKEN FEEDTHROUGH WIRE AND THE SUBSEQUENT LOSS OF PACING THERAPY AND INABILITY TO SUCCESSFULLY CHARGE. OVER TIME, THE MOVEMENT OF THE LOOSE HEADER ALSO RESULTED IN THE BROKEN ANCHOR POST, WHICH ALLOWED THE BODY FLUID TO ENTER THE DEVICE. THIS ALSO CAUSED A HIGH CURRENT DRAIN, WHICH RESULTED IN PREMATURE BATTERY DEPLETION AND THE LOSS OF TELEMETRY. IMPROVEMENTS HAVE BEEN MADE TO THE MANUFACTURING PROCESS IN ORDER TO STRENGTHEN THE BOND BETWEEN THE HEADER AND THE DEVICE CASE.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY BEING ANALYZED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS UNABLE TO BE INTERROGATED AFTER SEVERAL TROUBLESHOOTING TECHNIQUES WERE TRIED WITH NO SUCCESS. IT IS BELIEVED THAT THE DEVICE BATTERY DEPLETED PREMATURELY. AS A RESULT, THE DEVICE WAS EXPLANTED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155476 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Hospitalization| L| R 1851| 4461| T125| E110| 0144