BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3052720 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05466
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 3, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 RIGHT VENTRICULAR (RV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED A HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THE PATIENT WAS SEEN IN CLINIC FOR FOLLOW UP WHERE THE SHOCK IMPEDANCE WAS 94 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES DISCUSSED WITH THE LOCAL FIELD REPRESENTATIVE (FR) THAT AT IMPLANT THE SHOCKING IMPEDANCES WERE AROUND 50-60 OHMS. THE IMPEDANCE THEN BEGAN INCREASING TO A RANGE BETWEEN 90 AND 110 OHMS. THE FR INDICATED THAT ALL OF OTHER LEAD DIAGNOSTICS FROM THE PATIENT'S FOLLOW UP VISIT WERE WITHIN RANGE. THE PATIENT WILL CONTINUE TO BE MONITORED. THE LEAD AND DEVICE REMAIN IN SERVICE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156168 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR 4087| 0180| 4517| 5076| N118| H175