BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2910887 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-17163
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    October 30, 2012
    Report Date
    November 12, 2012
    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 THE REMOTE HOME MONITORING SYSTEM ISSUED AN ALERT FOR A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S TACHYCARDIA THERAPY HAD BEEN PROGRAMMED OFF FOR HOSPICE CARE DUE TO END STAGE CANCER. NO FURTHER INVESTIGATION WOULD BE PERFORMED. NO ADVERSE PATIENT EFFECTS DUE TO THE OUT OF RANGE IMPEDANCE MEASUREMENT WERE NOTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S TACHYCARDIA THERAPY HAD BEEN PROGRAMMED OFF FOR HOSPICE CARE DUE TO END STAGE CANCER. THIS WOULD EXPLAIN WHY THE OUT OF RANGE IMPEDANCE MEASUREMENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18482 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR T165| 1290| 4470| E110| 0184| 4469| T125