BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1301063 · Received January 30, 2009

    Report

    Report Number
    2029203-2009-00191
    Event Type
    Injury
    Date Received
    January 30, 2009
    Report Date
    December 31, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE REPORT WAS RECEIVED THAT THE PATIENT'S PRECISION SYSTEM WAS EXPLANTED. THE PATIENT STATED THE LEADS WERE PLACED HIGH IN THE NECK AREA TO HELP RELIEVE HER HEADACHES, BUT THIS MADE THE PAIN WORSE.

    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 58 YR Required Intervention LEAD EXTENSION| LINEAR LEA (PHASE IIIA)