BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2013-11382

    MDR report key: 3231965 · Received July 17, 2013

    Report

    Report Number
    2124215-2013-11382
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    May 29, 2013
    Report Date
    July 17, 2013
    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.

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT TROUBLESHOOTING REVEALED THAT THE PROGRAMMER WANT CONNECTOR WASN'T PLUGGED IN PROPERLY. THE ISSUE RESOLVED AFTER THE WAND CONNECTOR WAS PROPERLY PLUGGED INTO THE PROGRAMMER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEVICE WAS UNABLE TO BE INTERROGATED WITH A PROGRAMMER. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REQUESTED MORE INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION WAS AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331144 LWS GUIDANT PUERTO RICO BV EXTERNAL

    Patients

    Seq Age Sex Outcome Treatment
    1