BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3955938 · Received July 24, 2014

    Report

    Report Number
    2124215-2014-14313
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 14, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALL AVAILABLE INFORMATION INDICATES THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD SYSTEM EXHIBITED HIGH PACING, LEAD IMPEDANCE MEASUREMENT GREATER THAN 2,000 OHMS. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD REPRESENTATIVE INDICATED THAT THE CAUSE OF THE OBSERVATION WAS NOT DETERMINED. THE PATIENT WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433344 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR E102| 0184| T175