BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4149649 · Received October 7, 2014

    Report

    Report Number
    2124215-2014-16064
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    July 31, 2014
    Report Date
    August 7, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 VIA THE PATIENT'S REMOTE MONITORING SYSTEM THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) SHOCK LEAD IMPEDANCE. HOWEVER, IN THE OFFICE THE IMPEDANCE MEASUREMENT WAS BACK TO NORMAL IN 80-90 OHMS RANGE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED TREND AND IMPEDANCE MEASUREMENT WAS STABLE BETWEEN 80 TO 90 OHMS RANGE. OTHER LEAD DIAGNOSTICS APPEARED CONSISTENT AND NO EPISODES IN LOGBOOK NOTED AND PRESENTING ELECTROGRAM (EGM) IS UNREMARKABLE. TS DISCUSSED POSSIBLE CAUSES. ADDITIONAL INFORMATION INDICATED THAT THE CAUSE WAS UNDETERMINED AND THE PATIENT WILL CONTINUE TO BE MONITORED. THE SYSTEM REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629621 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR E142| 4469| 0292