BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2223501 · Received August 25, 2011

    Report

    Report Number
    3006630150-2011-01315
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD NOT HAD A BOWEL MOVEMENT SINCE BEING IMPLANTED. THE PATIENT WAS HOSPITALIZED, AND GIVEN IV FLUIDS ALONG WITH ANXIETY MEDICATION. THE PATIENT HAD SERVERE CONSTIPATION RELATED TO THE ANESTHESIA. THE PATIENT WAS RELEASED FROM THE HOSPITAL AND 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 53 YR Hospitalization| R