BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3090608 · Received May 2, 2013

    Report

    Report Number
    3006630150-2013-00861
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT HIS POCKET SITE. DATABASE ANALYSIS REVEALED THAT THE DEVICE WAS WORKING PROPERLY. THE PHYSICIAN ADMINISTERED CORTISONE MEDICATIONS ON THE PATIENT'S AFFECTED AREA. THE PATIENT WAS DOING WELL AND THE PAIN ON THE POCKET SITE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192345 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention