BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1285819 · Received January 9, 2009

    Report

    Report Number
    2029203-2009-00012
    Event Type
    Injury
    Date Received
    January 9, 2009
    Date of Event
    January 1, 2008
    Report Date
    December 12, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT THAT THE PATIENT'S PRECISION SYSTEM WAS EXPLANTED WAS RECEIVED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LINEAR LEAD (PHASE IIIA)| LEAD EXTENSION