BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2200104 · Received August 10, 2011

    Report

    Report Number
    3006630150-2011-01257
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 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

    THERE WERE NO REPORTED COMPLAINTS ABOUT THE FUNCTIONALITY OF THE SCS SYSTEM. THE EXPLANTED IPG PASSED VISUAL, PHOTOGRAPHIC IMAGING, ELECTRICAL AND PERFORMANCE TESTS DONE. THE IPG EXHIBITS NORMAL DEVICE CHARACTERISTICS. THE ROOT CAUSE OF THE REPORTED POCKET PAIN IS UNKNOWN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A POCKET REVISION AS THE PATIENT WAS EXPERIANCING PAIN. THE PATIENT POCKET WAS OPENED DUE TO PATIENT'S OTHER MEDICAL CONDITIONS. DURING THE PROCEDURE THE PHYSICIAN EXPLANTED THE IPG. THE PATIENT IS REPORTEDLY DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A POCKET REVISION AS THE PATIENT WAS EXPERIANCING PAIN. THE PATIENT POCKET WAS OPENED DUE TO PATIENT'S OTHER MEDICAL CONDITIONS. DURING THE PROCEDURE THE PHYSICIAN EXPLANTED THE IPG. THE PATIENT IS REPORTEDLY DOING WELL.

    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