BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3210890 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08113
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 1, 2013
    Report Date
    September 17, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    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 DEVICE AND RIGHT VENTRICULAR (RV) LEAD CAUSED A RED ALERT TO BE DECLARED DUE TO HIGH SHOCK IMPEDANCES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE HIGH, OUT-OF-RANGE SHOCKING IMPEDANCE ISSUE IS STILL ONGOING. IT WAS REPORTED THAT THE PATIENT HAD A HIGH SHOCKING IMPEDANCE SINCE IMPLANT AT AROUND 110 OHMS. HOWEVER, THE MEASUREMENTS WERE CONSIDERED STABLE AND NO LEAD ISSUES WERE SUSPECTED. ALL OTHER MEASUREMENTS WERE WITHIN NORMAL RANGE AND NO NOISE WAS RECORDED. NO REVISION WAS PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311750 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening