BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053232 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04757
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 11, 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 THE REMOTE HOME MONITORING SYSTEM ISSUED AN ALERT FOR LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THE PATIENT WAS BROUGHT INTO THE CLINIC FOR FURTHER TESTING WHERE THEY WERE UNABLE TO REPRODUCE THE OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. IT WAS NOTED THAT ALL OTHER MEASUREMENTS WERE WITHIN NORMAL LIMITS. SUBSEQUENTLY NO FURTHER TESTING WAS PERFORMED AND THE PHYSICIAN OPTED TO CONTINUE TO MONITOR THE PATIENT VIA THE REMOTE HOME MONITORING SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154557 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR N160| 0295| 4549| 5076