BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 4131481 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14431
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 7, 2014
    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

    (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 PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND COMPETITOR RIGHT VENTRICULAR LEAD EXHIBITED A LOW SHOCK IMPEDANCE MEASUREMENT OF LESS THAN 20 OHMS. ADDITIONAL INFORMATION MADE AVAILABLE FROM THE FIELD INDICATED THAT THE CAUSE OF THE IMPEDANCE ISSUE WAS UNKNOWN AND THAT DURING FOLLOW-UP, THERE WAS NO LOW SHOCK IMPEDANCE MEASUREMENT. FOR NOW, THE ICD REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611375 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR MISMATCH| E110