BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 4132270 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14668
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    October 17, 2012
    Report Date
    July 25, 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). 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 EXHIBITED PACING IMPEDANCES GREATER THAN 2,000 OHMS. IT WAS DISCOVERED THAT THE IMPEDANCE VALUES HAVE CONSISTENTLY RAN HIGH PER IMPEDANCE TRENDING GRAPHS. NO FURTHER ACTION WAS PERFORMED. ADDITIONAL INFORMATION WAS PROVIDED THAT THIS SYSTEM CONTINUES TO EXHIBIT HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS. THERE WAS ONE STORED NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODE WITH A COUPLE NON-PHYSIOLOGIC SIGNALS DETECTED OVER A YEAR AGO; HOWEVER, NO FURTHER EPISODES HAVE BEEN DETECTED. THE PATIENT WAS EVALUATED IN THE OFFICE AND NO FURTHER ACTION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612621 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR 1860| 0154| E102| 0145