BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2160442 · Received July 13, 2011

    Report

    Report Number
    3006630150-2011-01022
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#:SC-2218-70 (B)(4) AND (B)(4) MODEL DESCRIPTION: ST LINEAR LEAD, 70CM WITH PRE-LOADED 0.014 INCH STYLET 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING POCKET SITE PAIN AND HIS LEGS WERE SHAKING. THE PHYSICIAN DISCOVERED THAT THE PATIENT'S LEADS HAD MIGRATED OUT OF THE EPIDURAL SPACE. THE PHYSICIAN WAS NOT SURE IF THE PATIENT'S SYMPTOMS WERE DEVICE RELATED. THE PATIENT REQUESTED TO BE EXPLANTED AND WAS REPORTEDLY DOING WELL FOLLOWING THE EXPLANT

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING POCKET SITE PAIN AND HIS LEGS WERE SHAKING. THE PHYSICIAN DISCOVERED THAT THE PATIENT'S LEADS HAD MIGRATED OUT OF THE EPIDURAL SPACE. THE PHYSICIAN WAS NOT SURE IF THE PATIENT'S SYMPTOMS WERE DEVICE RELATED. THE PATIENT REQUESTED TO BE EXPLANTED AND WAS REPORTEDLY DOING WELL FOLLOWING THE EXPLANT

    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 81 YR Required Intervention