BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1024305 · Received April 3, 2008

    Report

    Report Number
    2029203-2008-00208
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    2029203-10/17/07-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PROGRAMMING SESSION, COMMUNICATION ISSUES WERE OBSERVED BETWEEN THE IMPLANT AND THE EXTERNAL EQUIPMENT. A COMPANY REPRESENTATIVE PERFORMED DEVICE EVALUATION. THE PROBLEM WAS CONFIRMED. EXPLANT SURGERY HAS BEEN RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LEAD LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1