BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1172087 · Received September 23, 2008

    Report

    Report Number
    2029203-2008-00611
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    August 24, 2008
    Report Date
    August 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORTION
    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

    A REPORT OF PAIN AT THE POCKET SITE WAS RECEIVED. THE PATIENT FEELS A BURNING SENSATION AT THE POCKET SITE AND FEELS LIKE THE IMPLANT IS MIGRATING OUT THROUGH HIS SKIN. THE PATIENT WAS ADVISED TO CONTACT HIS PHYSICIAN OR PROCEED TO THE EMERGENCY ROOM.

    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 UNK Required Intervention