BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3210840 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07425
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 26, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD DISPLAYED AN OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THE LOCAL FIELD REPRESENTATIVE REPORTED THAT THE SHOCKING IMPEDANCE HAD BEEN TRENDING ON THE HIGH SIDE SINCE IMPLANT. THE PATIENT WAS TO CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE PATIENT EFFECTS. THE SYSTEM REMAINS IN SERVICE.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THE SYSTEM DISPLAYED ADDITIONAL HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311672 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 4574| ADDRL1| E110| 4074