BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2162428 · Received July 14, 2011

    Report

    Report Number
    3006630150-2011-01075
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A POCKET REVISION DUE TO DIFFICULTY CHARGING AND DISCOMFORT AT THE POCKET SITE. THE PATIENT IS DOING WELL FOLLOWING THE REVISION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention