BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1760755 · Received July 15, 2010

    Report

    Report Number
    3006630150-2010-01196
    Event Type
    Injury
    Date Received
    July 15, 2010
    Date of Event
    June 19, 2010
    Report Date
    June 19, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORP
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN FOR ANALYSIS AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PT'S PRECISION SYSTEM WAS EXPLANTED DUE TO AN INFECTION AT THE LEAD AND IPG SITES. THE PT WAS EXPERIENCING DISCOLORED FLUID DRAINING FROM THE POCKET SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORP SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention ARTISAN 2X8 PADDLE LEAD (LIM), 70 CM:| MODEL # SC-8216-70, SERIAL # (B)(4)