BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1162838 · Received September 16, 2008

    Report

    Report Number
    2029203-2008-00631
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 17, 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 PATIENT REPORTED INEFFECTIVE THERAPY. THE PHYSICIAN DECIDED TO EXPLANT THE SYSTEM.

    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 MODEL # SC-2138-50| DESCRIPTION: LINEAR LEAD (PHASE IIIA)| DESCRIPTION: LINEAR LEAD (PHASE IIIA)| MODEL #:SC-2138-50| MODEL #:SC-2138-50| DESCRIPTION: LINEAR LEAD (PHASE IIIA)