BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2911930 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16236
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 29, 2012
    Report Date
    February 15, 2013
    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

    ADDITIONAL INFORMATION HAS BEEN PROVIDED THAT THIS IS A DEVICE SPECIFIC ISSUE, NOT A LEAD ISSUE

    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 RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE LOW SHOCK IMPEDANCE MEASUREMENTS LESS THAN 20 OHMS. NO OTHER COMPLICATIONS HAVE BEEN REPORTED. THE PHYSICIAN PLANS TO CONTINUE TO MONITOR THIS PATIENT AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18717 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 0184| E110| 4469