BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2073832 · Received May 2, 2011

    Report

    Report Number
    3006630150-2011-00619
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    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 (B)(4) MODEL DESCRIPTION:ARTISAN 2X8 PADDLE LEAD (LIM), 70 CM THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN BECAUSE 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 THE PATIENT'S PRECISION SYSTEM WAS EXPLANTED DUE TO AN INFECTION. THE PATIENTS SYMPTOM WAS PUS COMING OUT OF BOTH INCISION SITES. THE PATIENT WAS GIVEN IV ANTIBIOTICS. THE PHYSICIAN DOES NOT THINK THE INFECTION WAS DEVICE OR PROCEDURE RELATED BUT THINKS THE INFECTION WAS CAUSED BY THE PATIENT BEING NON COMPLIANT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S PRECISION SYSTEM WAS EXPLANTED DUE TO AN INFECTION. THE PATIENTS SYMPTOM WAS PUS COMING OUT OF BOTH INCISION SITES. THE PATIENT WAS GIVEN IV ANTIBIOTICS. THE PHYSICIAN DOES NOT THINK THE INFECTION WAS DEVICE OR PROCEDURE RELATED BUT THINKS THE INFECTION WAS CAUSED BY THE PATIENT BEING NON COMPLIANT.

    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 42 YR Required Intervention