BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2905536 · Received January 9, 2013

    Report

    Report Number
    2124215-2012-13665
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 THE RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE MEASUREMENT INCREASED PROGRESSIVELY UNTIL IT WAS GREATER THAN 2500 OHMS. WHEN THE CHRONIC DEVICE (H195) HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) IT WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. AFTER THE NEW DEVICE (P165) WAS CONNECTED TO THE RV LEAD PACING IMPEDANCE MEASUREMENTS WERE GREATER THAN 3000 OHMS. ALL OTHER LEAD MEASUREMENTS WERE APPROPRIATE. THEREFORE, THE RV LEAD AND NEW DEVICE REMAIN IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11231 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1