BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2122294 · Received June 13, 2011

    Report

    Report Number
    3006630150-2011-00899
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 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
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL# SC-2218-50 SERIAL# (B)(4) DESCRIPTION: ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014 INCHES STYLET MODEL# SC-2218-70 SERIAL# (B)(4) DESCRIPTION: ST LINEAR LEAD, 70CM WITH PRE-LOADED 0.014 INCHES STYLET MODEL# SC-3354-25 SERIAL# (B)(4) DESCRIPTION: W4 SPLITTER 2X4-25 CM MODEL# SC-3304-25 SERIAL# (B)(4) DESCRIPTION: 2X4 SPLITTER - D4 - 25 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN FOR EVALUATION AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED DEVICES FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION RECORDS OF 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 AT THE POCKET SITE. THE PATIENT'S SYMPTOM WAS REDNESS AT THE POCKET SITE. THE PHYSICIAN PLACED THE PATIENT ON ORAL AND IV ANTIBIOTICS AND BELIEVES THE INFECTION WAS CAUSED BY THE HAIR ON THE PATIENT'S BACK. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT'S PRECISION SYSTEM WAS EXPLANTED DUE TO AN INFECTION AT THE POCKET SITE. THE PATIENT'S SYMPTOM WAS REDNESS AT THE POCKET SITE. THE PHYSICIAN PLACED THE PATIENT ON ORAL AND IV ANTIBIOTICS AND BELIEVES THE INFECTION WAS CAUSED BY THE HAIR ON THE PATIENT'S BACK. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    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 60 YR Required Intervention