BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2041706 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01393
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 14, 2011
    Report Date
    April 9, 2012
    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

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE DEVICE WAS EXPOSED TO AUTOMATED DIAGNOSTIC TESTS THAT VERIFIED THE PERFORMANCE OF PACING, SENSING AND RECORDING FUNCTIONS OF THE DEVICE AND NO ANOMALIES WERE FOUND. THIS DEVICE PERFORMED NORMALLY THROUGHOUT ANALYSIS, OPERATING AS DESIGNED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED STATES THAT THIS DEVICE WAS REMOVED FROM SERVICE AND UPGRADED TO A BIV ICD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEVICE OVERSENSED ATRIAL FIBRILLATION ON THE RIGHT VENTRICULAR CHANNEL. PACING WAS INHIBITED. THE RIGHT VENTRICULAR AGC WAS REPROGRAMMED TO A LESS SENSITIVE SETTING. CURRENTLY, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS 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 71 YR (B)(4)| (B)(4)| (B)(4)