BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 6020097 · Received October 12, 2016

    Report

    Report Number
    2124215-2016-14572
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    July 9, 2016
    Report Date
    July 9, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P960040/S155
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD AND DEVICE REMAIN 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 RIGHT VENTRICULAR (RV) LEAD AND ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. THE MEASUREMENTS HAD BEEN CHRONICALLY HIGH AROUND 110-120 OHMS, WITH SOME MEASUREMENTS IN THE 90-100 OHMS RANGE. THE PACING IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL RANGE, AND NO NOISE WAS PRESENT. IN THE OFFICE, THE SHOCK IMPEDANCE WAS 116 OHMS. THE PROGRAMMABLE LIMIT FOR SHOCK IMPEDANCE ALERTS WAS 125 OHMS; THE LIMIT WILL NOT BE CHANGED AND THE PATIENT AND LEAD WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672082 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR (B)(4)| (B)(4)| (B)(4)