BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1953443 · Received January 5, 2011

    Report

    Report Number
    3006630150-2010-02215
    Event Type
    Injury
    Date Received
    January 5, 2011
    Date of Event
    December 12, 2010
    Report Date
    December 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    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

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT DEVELOPED AN INFECTION, 6 INCHES ABOVE THE INCISION SITE. THE PATIENT'S SYMPTOMS WERE REDNESS, SWELLING AND DRAINAGE. THE PATIENT WAS PRESCRIBED IV ANTIBIOTICS. THE PATIENT IS HEALING WELL. THE PHYSICIAN DOESN'T BELIEVE THE INFECTION IS RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention