BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2924935 · Received January 22, 2013

    Report

    Report Number
    2124215-2013-01523
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 18, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATES SHOULD ADDITIONAL INFORMATION BE OBTAINED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AN OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS WAS OBSERVED. IT WAS REPORTED SINCE IMPLANT THE TREND HAS BEEN FLUCTUATING BETWEEN 70 - 90 OHMS. THE OUT OF RANGE MEASUREMENT WAS ONLY OBSERVED ONCE. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30751 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR E102| 0181