BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2111559 · Received June 2, 2011

    Report

    Report Number
    3006630150-2011-00816
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#:SC-2218-50E (B)(4) 7 DESCRIPTION:ENH ST TRIAL LD KIT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED THAT THE PHYSICIAN DOES NOT FEEL THAT THE EVENT WAS DEVICE RELATED. THE PHYSICIAN ASSESSED THAT IT WAS DUE TO ACUTE ONSET OF CRPS AS A RESULT OF POSSIBLY IRRITATING THE NERVE ROOT WHILE INSERTING THE ELECTRODES INTO THE EPIDURAL SPACE. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE LEADS REVEALED NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE REPORTED EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A TRIAL IMPLANT PROCEDURE THE PATIENT STARTED EXPERIENCING SEVERE PAIN DOWN HIS RIGHT LEG. THE PHYSICIAN BELIEVED IT TO BE NERVE ROOT IRRITATION AND DECIDED TO EXPLANT ALL LEADS FROM THE PATIENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A TRIAL IMPLANT PROCEDURE THE PATIENT STARTED EXPERIENCING SEVERE PAIN DOWN HIS RIGHT LEG. THE PHYSICIAN BELIEVED IT TO BE NERVE ROOT IRRITATION AND DECIDED TO EXPLANT ALL LEADS FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R