BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2122296 · Received June 13, 2011

    Report

    Report Number
    3006630150-2011-00901
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL# SC-8216-70 SERIAL# (B)(4) DESCRIPTION: ARTISAN 2X8 PADDLE LEAD (LIM), 70 CM MODEL# SC-2218-50E SERIAL# (B)(4) DESCRIPTION:ST LINEAR TRIAL LEAD, 50CM WITH PRE-LOADED 0.014 INCHES STYLET (STREAMLINED) MODEL#SC-2218-70T SERIAL# (B)(4) DESCRIPTION: ST LINEAR TRIAL LEAD, 70CM WITH PRE-LOADED 0.014 INCHES STYLET. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN FOR EVALUATION AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE EXPLANTED DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE EXPLANTED DEVICES FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT'S PRECISION SYSTEM WAS EXPLANTED DUE TO AN INFECTION. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND IS REPORTEDLY DOING WELL FOLLOWING TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R