BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1871646 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-18147
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    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

    TO DATE, INFORMATION SUGGESTS THAT THESE MEDICAL DEVICES REMAIN ACTIVELY IN SERVICE. AS NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE TRANSVENOUS IMPLANTABLE RIGHT VENTRICULAR (RV) LEAD IN ASSOCIATION WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED >125 OHMS SHOCK IMPEDANCE VALUES INTERMITTENTLY POST-IMPLANT. IT WAS NOT KNOWN AT THE TIME WHETHER A LOOSE CONNECTION OR ELECTROMAGNETIC INTERFERENCE (EMI) OR SOME OTHER ISSUE MAY BE PRESENT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)