BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2051952 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03467
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LATITUDE SYSTEM DETECTED A RED ALERT FROM THIS TRANSVENOUS DEFIBRILLATION LEAD DUE TO LOW SHOCK IMPEDANCES OF LESS THAN 20 OHMS. TECHNICAL SERVICES (TS) DISCUSSED THE CLINICAL EVENT TRIGGERED THE RED ALERT FOR LESS THAN 20 OHMS SHOCK IMPEDANCE; HOWEVER, THE TRENDING WINDOW HAD NOT ENDED SO THE DEVICE WAS NOT PROVIDING THE ACTUAL VALUE YET. TS DISCUSSED THE POTENTIAL FOR A SHORT IN THE DEVICE AND/OR LEAD, AND THAT THERAPY MAY NOT BE AVAILABLE. TS ALSO DISCUSSED TROUBLESHOOTING AND PROGRAMMING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR T177| N119| 4136| 1850| 4554| 0157