BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1222038 · Received November 6, 2008

    Report

    Report Number
    2029203-2008-00868
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 8, 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
    EI
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING THAT AFTER RE-INJURING HERSELF, THE PATIENT NO LONGER HAD SUFFICIENT PAIN COVERAGE AND WAS ALSO EXPERIENCING SHOCKING STIMULATION. THE PHYSICIAN BELIEVED THE IPG WAS THE SOURCE OF THE PROBLEM. DURING THE REVISION THE IPG WAS DETERMINED NOT TO BE THE CAUSE OF THE PROBLEM AND WAS RE-IMPLANTED IN THE PATIENT. AFTER THE REVISION, THE PATIENT WAS RE-PROGRAMMED AND SATISFACTORY PAIN COVERAGE WAS ACHIEVED. DURING THE PROGRAMMING, THE SHOCKING SENSATION, THE PATIENT WAS EXPERIENCING WAS DUPLICATED BASED ON AMPLITUDES AND THE PATIENT'S POSTURAL POSITION.

    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