BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 4132029 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14221
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 29, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR TESTING. THIS PRODUCT ISSUE WILL BE UPDATED WHEN DEVICE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. ATTEMPTS TO INTERROGATE THE DEVICE WERE UNSUCCESSFUL. THE DEVICE CASE WAS REMOVED AND IT WAS DETERMINED THE BATTERY VOLTAGE WAS MUCH LOWER THAN EXPECTED. AN EXTERNAL POWER SUPPLY WAS CONNECTED TO THE DEVICE. WHEN THE DEVICE WAS POWERED UP, A HIGH CURRENT CONDITION WAS DISCOVERED. DETAILED ANALYSIS OF THE INTERNAL COMPONENTS WAS UNDERTAKEN. THE MIXED MODE INTEGRATED CIRCUIT WAS FOUND TO HAVE CRACKS ON IT. THE CRACKS WERE DETERMINED TO HAVE BEEN INDUCED; HOWEVER, IT IS UNKNOWN WHEN THE DAMAGE WAS INCURRED. THE DEVICE CASE IS UNBLEMISHED AND NO OTHER ANOMALIES WERE NOTED. NO FURTHER ANALYSIS WAS POSSIBLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT INTERROGATION OF THIS DEVICE WAS UNSUCCESSFUL DESPITE THE USE OF THREE PROGRAMMERS, NEW WANDS AND A DIFFERENT ROOM. ADDITIONALLY, NO MAGNET TONES WERE AUDIBLE. THEREFORE, THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT FURTHER INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610367 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L E102| 0184