BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2894452 · Received January 3, 2013

    Report

    Report Number
    3006630150-2012-02438
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    October 13, 2012
    Report Date
    November 1, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING BURNING SENSATION AT THE POCKET SITE AND WAS HAVING CHARGING DIFFICULTY DUE TO THE IPG BEING TILTED. THE PATIENT UNDERWENT A POCKET REVISION AND WAS DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2951 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention