BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3211153 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-10138
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS DURING A ROUTINE DEVICE CHECK. SLIGHT NOISE WAS OBSERVED ON THE SHOCK CHANNEL WHEN ISOMETRICS WAS PERFORMED. ALL OTHER LEAD MEASUREMENTS WERE ACCEPTABLE AND STABLE. AN INVASIVE PROCEDURE WAS PERFORMED. THIS LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310367 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L| R A155| 4469| 0184| E110