BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 2241892 · Received September 9, 2011

    Report

    Report Number
    3006630150-2011-01459
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT AFTER A POLYGRAPH TEST, THE PATIENT WAS EXPERIENCING SWELLING, PAIN, AND A BURNING SENSATION AT THE POCKET SITE. THE PATIENT IS EXPERIENCING THESE SYMPTOMS WITH THE DEVICE ON AND OFF. THE PATIENT WAS PRESCRIBED A LIDOCAINE PATCH TO RELIEVE THESE SYMPTOMS. THE PATIENT IS NO LONGER EXPERIENCING THESE SYMPTOMS AFTER THE PATCH WAS PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention