BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3040769 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01729
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    February 13, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN ELECTED NOT TO PERFORM NON-INVASIVE PROGRAMMED STIMULATION (NIPS) DUE TO THERE ONLY BEING ONE OUT OF RANGE IMPEDANCE. THE PATIENT WILL CONTINUE TO BE MONITORED. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL DETAILS ARE RECEIVED.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED THAT THIS IS A DEVICE SPECIFIC ISSUE, NOT A LEAD ISSUE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION A LATITUDE RED ALERT WAS GENERATED FROM THIS SYSTEM DUE TO SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143369 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR 4469| 0184| 0180| E110