BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2173384 · Received July 23, 2011

    Report

    Report Number
    3006630150-2011-01058
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS EXPERIENCING DISCOMFORT AT THE POCKET SITE AFTER NON DEVICE RELATED WEIGHT LOSS. THE PHYSICIAN PERFORMED A POCKET REVISION PROCEDURE WHERE THE POCKET SITE WAS MOVED TO A MORE COMFORTABLE LOCATION.

    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 55 YR Required Intervention