BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2780137 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12216
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 7, 2012
    Report Date
    October 28, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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.

    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 CARDIOVERTER DEFIBRILLATOR (ICD) CAUSES A RED ALERT TO BE DECLAIRED DUE TO HIGH SHOCK IMPEDANCES. THE PATIENT'S PHYSICAN IS AWARE OF THE SITUATION AND THE PATIENT WILL BE MONITORED AS THE PACING SYSTEM REMAINS IMPLANTED AT THIS TIME. (THE RIGHT VENTRICULAR (RV) LEAD MODEL/SERIAL NUMBER ARE UNKNOWN AT THIS TIME) NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE CONTINUED TO EXHIBIT HIGH SHOCK LEAD IMPEDANCE MEASUREMENTS. RECENT DEVICE FOLLOW UP SHOWED NORMAL IMPEDANCE MEASUREMENT VALUES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 4470| F102| 0181| F110| 0165| 1871