BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2040098 · Received April 5, 2011

    Report

    Report Number
    2124215-2011-00362
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    October 28, 2010
    Report Date
    January 4, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    DEFIBRILLATION THRESHOLD TESTING WAS PERFORMED, RESULTING IN SHOCK IMPEDANCE MEASUREMENTS WITHIN NORMAL LIMITS. THE PATIENT'S PHYSICIAN WAS AWARE OF THE OUT OF RANGE IMPEDANCE MEASUREMENT AND HAD NOT ELECTED FOR FURTHER INTERVENTION AT THIS TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT VARYING SHOCK IMPEDANCE MEASUREMENTS WERE DETECTED ON THIS DEVICE SYSTEM. THE MEASUREMENTS REMAINED WITHIN ACCEPTABLE LIMITS. APPROXIMATELY TWO MONTHS LATER, A SHOCK IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS WAS OBSERVED. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED FOR THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT IMPLANTED WITH THIS DEVICE SYSTEM WAS TO BE BROUGHT INTO THE CLINIC FOR DEFIBRILLATION THRESHOLD TESTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R 0147| T135| E102