BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2153130 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-09169
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 8, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THIS ICD NOTED NO ANOMALIES. ATTEMPTS TO INTERROGATE THE DEVICE WERE UNSUCCESSFUL. AN X-RAY OF THE DEVICE WAS COMPLETED AND NO IRREGULARITIES WERE IDENTIFIED. THE DEVICE CASE WAS OPENED IN ORDER FOR THE INTERNAL COMPONENTS TO BE ASSESSED. DETAILED ANALYSIS DETERMINED THE INABILITY TO INTERROGATE THIS DEVICE WAS DUE TO AN INTERNAL SHORT WITHIN THE TRANSFORMER WHICH RESULTED IN DAMAGE THROUGHOUT INTERNAL CIRCUITRY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT REPORTED NOT BEING ABLE TO PERFORM A PATIENT INITIATED INTERROGATION (PII) VIA LATTITUDE. TROUBLESHOOTING WAS PERFORMED AND THE ASSOCIATED COMMUNICATOR WAS REPLACED. HOWEVER, INTERROGATION WAS STILL UNSUCCESSFUL. THEREFORE, THE PATIENT SCHEDULED AN OFFICE VISIT AND INTERROGATION WAS UNSUCCESSFUL AND NO MAGNET RATE COULD BE OBTAINED. ADDITIONALLY, THE PATIENT'S RATE WAS 47-67 BPM AND THE PHYSICIAN BELIEVES THE PROGRAMMED RATE WAS 85PPM. THE DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 76 YR T165| 0185| 4063| 4034| E110| 4472| 1291| 4086