BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2013-08496

    MDR report key: 3210326 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08496
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST WAS MADE FOR ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS WERE REPORTED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A RED ALERT WAS ISSUED IN THE PATIENT'S REMOTE MONITORING SYSTEM FOR A HIGH, OUT-OF-RANGE IMPEDANCE MEASUREMENT. THE CLINICIAN REPORTED THAT THE FUNCTION FOR THE RED ALERT HAD BEEN PROGRAMMED OFF, OTHERWISE THE RED ALERT WAS ALWAYS DISPLAYED FOR THE PATIENT. THE CLINICIAN ASKED WHY THE RED ALERT WAS DISPLAYED STILL. THE DETAILS ABOUT THE RED ALERT WERE NOT KNOWN, IN RELATION TO WHICH LEAD AND WHICH MEASUREMENT WAS HIGH. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310425 LWS GUIDANT PUERTO RICO BV TACHY DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1