BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2183153 · Received July 28, 2011

    Report

    Report Number
    3006630150-2011-01211
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED LEADS REVEALED NO ANOMALIES OR DEVIATIONS OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOUND THEM TO BE SATISFACTORY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#:SC-2352-50E, (B)(4), DESCRIPTION: LINEAR 3-4 TRIAL LEAD 50CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT TRIAL PATIENT WAS EXPLANTED DUE TO A BLOOD INFECTION. THE PATIENT'S SYMPTOMS WERE GREENISH YELLOW, ODOROUS, DRAINAGE FROM THE LEAD INCISION SITE. THE PATIENT WAS PRESCRIBED IV ANTIBIOTICS. THE INFECTION IS BELIEVED TO BE RELATED TO THE IMPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT TRIAL PATIENT WAS EXPLANTED DUE TO A BLOOD INFECTION. THE PATIENT'S SYMPTOMS WERE GREENISH YELLOW, ODOROUS, DRAINAGE FROM THE LEAD INCISION SITE. THE PATIENT WAS PRESCRIBED IV ANTIBIOTICS. THE INFECTION IS BELIEVED TO BE RELATED TO THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-50E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R