BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2052624 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03792
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 ANOTHER MANUFACTURER'S RIGHT VENTRICULAR DEFIBRILLATION (RV) LEAD WERE EXHIBITING HIGH OUT OF RANGE SHOCKING IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. THERE HAD BEEN REPORTS OF ERRATIC MEASUREMENTS BETWEEN 50-125 OHMS. THE PACING IMPEDANCES MEASUREMENTS WERE WITHIN NORMAL RANGE. A 41 JOULE SHOCK HAD RECENTLY BEEN DELIVERED WHICH SUCCESSFULLY CONVERTED THE PATIENT WITH A 70 OHMS SHOCK IMPEDANCE. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT RECOMMENDED THE HEALTH CARE PROFESSIONAL TO CONTACT THE MANUFACTURER OF THE RV LEAD TO DETERMINE ANY FURTHER TROUBLESHOOTING AS IT COULD BE THE START TO A LEAD PROBLEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR MISMATCH| 1850| T135| 6963| E102