BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2014-14597

    MDR report key: 4132069 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14597
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 DURING THRESHOLD TESTING WITH THIS PACEMAKER, WHEN THE STOP TEST BUTTON WAS PRESSED ON THE PROGRAMMER, A DELAY WAS OBSERVED IN STOPPING THE TEST RESULTING IN A PAUSE IN PACING FOR AN UKNOWN DURATION REQUIRING STAT PACE TO BE PRESSED. A HEALTH CARE PROFESSIONAL (HCP) CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) TO INQUIRE ABOUT HOW TO GET BACK TO THE PREVIOUSLY PROGRAMMED PARAMETERS AND INQUIRED ABOUT TELEMETRY ISSUES. THE HCP REPORTED THAT STOP TEST WAS PRESSED FOUR TIMES BEFORE THE THRESHOLD TEST ENDED. TS DISCUSSED THRESHOLD TEST STEPS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611818 LWS GUIDANT PUERTO RICO BV EXTERNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR H125| 4087| 4086| V172| 4512