BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SC-1110-02

    MDR report key: 3083617 · Received April 29, 2013

    Report

    Report Number
    3006630150-2013-00849
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S POCKET SITE WAS UNCOMFORTABLE. THE PATIENT UNDERWENT POCKET REVISION WHEREIN THE IPG WAS RELOCATED. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185080 SC-1110-02 PRECISION® LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention