BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2773983 · Received October 5, 2012

    Report

    Report Number
    2124215-2012-09225
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    July 2, 2012
    Report Date
    July 2, 2012
    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 REMOTE MONITORING OF THIS DEVICE DISPLAYED A HIGH SHOCK LEAD IMPEDANCE MEASUREMENT.. THE PHYSICIAN WAS INFORMED AND IS FURTHER MONITORING THIS ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A FURTHER FOLLOW UP WAS PERFORMED. THIS OUT OF RANGE MEASUREMENT OCCURRED FOUR DAYS POST IMPLANT. IT WAS THOUGHT THIS WAS DUE TO THE LEAD IMPLANTED WAS A SINGLE COIL LEAD, BUT THE SETTINGS WERE NOT REPROGRAMMED FROM THE PREVIOUS DOUBLE COIL LEAD SETTING. THE DEVICE WAS REPROGRAMMED TO A SINGLE COIL LEAD SETTING. IT WAS THOUGHT THIS RESOLVED THE ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1