BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1933767 · Received December 16, 2010

    Report

    Report Number
    3006630150-2010-02182
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT WAS HAVING CHARGING AND COMMUNICATION ISSUES BECAUSE THE IPG WAS NOT LAYING FLAT IN THE POCKET. THE PT'S POCKET SITE WAS RELOCATED FROM THE BUTTOCKS TO THE STOMACH AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention