BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1083140 · Received July 24, 2008

    Report

    Report Number
    2029203-2008-00495
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    January 1, 2008
    Report Date
    June 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORTION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT OF COMMUNICATION AND CHARGING ISSUES BETWEEN THE IMPLANT AND EXTERNAL EQUIPMENT WAS REPORTED AFTER SUFFERING A FALL. THE SURGEON DECIDED TO REPLACE THE IMPLANT WITH A NEW BOSTON SCIENTIFIC SPINAL CORD STIMULATOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R