BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2132278 · Received June 17, 2011

    Report

    Report Number
    3006630150-2011-00908
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S IPG DATABASE WAS ANALYZED AND IT WAS DETERMINED THAT THE PATIENT WAS NOT CHARGING PROPERLY. THE PATIENT WAS NOT REVISED. A GOOD FAITH EFFORT WAS MADE TO CONTACT THE PATIENT WITH NO SUCCESS. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE DEVICE 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 DIFFICULTY CHARGING HER IPG. A BSN REPRESENTATIVE ATTEMPTED TO TROUBLESHOOT THE DEVICE BUT THE ISSUE WAS NOT RESOLVED. THE PHYSICIAN WILL REPLACE THE PATIENT'S IPG.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING HER IPG. A BSN REPRESENTATIVE ATTEMPTED TO TROUBLESHOOT THE DEVICE BUT THE ISSUE WAS NOT RESOLVED. THE PHYSICIAN WILL REPLACE THE PATIENTS IPG.

    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 45 YR Required Intervention