BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2220672 · Received August 23, 2011

    Report

    Report Number
    3006630150-2011-01307
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    May 26, 2010
    Report Date
    May 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT THE POCKET REVISION. THE POCKET WAS RELOCATED TO THE RIGHT BUTTOCKS DUE TO PHYSICIAN'S PREFERENCE. THE PATIENT WAS REPORTEDLY DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A POCKET REVISION DUE TO DISCOMFORT AT THE POCKET SITE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A POCKET REVISION DUE TO DISCOMFORT AT THE POCKET SITE.

    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 37 YR Required Intervention