BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1132652 · Received August 22, 2008

    Report

    Report Number
    2029203-2008-00541
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    May 23, 2007
    Report Date
    July 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODUALTION 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

    Additional Manufacturer Narrative · 1

    ADD'L SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-2138-50; DESCRIPTION: LINEAR LEAD (PHASE III A), 50 CM. THE EXPLANTED DEVICE WILL NOT BE EVALUATED AS IT WAS DISCARDED BY MEDICAL FACILITY.

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED REGARDING INFECTION. THE DOCTOR EXPLANTED PATIENT'S PRECISION SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention