BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1081241 · Received July 24, 2008

    Report

    Report Number
    2029203-2008-00470
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IPG WAS DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR EVAL. A REVIEW OF THE IPG'S STERILIZATION RECORDS WAS FOUND SATISFACTORY. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE PATIENT'S SYSTEM WAS EXPLANTED DUE TO A SUSPECTED INFECTION AT THE POCKET SITE. UPON EXPLANT IT WAS DETERMINED THERE WAS NO INFECTION, HOWEVER THE SYSTEM WAS PROTRUDING OUT OF THE SKIN AND WAS EXPLANTED.

    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 Hospitalization| R