BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2943589 · Received February 5, 2013

    Report

    Report Number
    3006630150-2013-00186
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT AFTER A TRIAL PROCEDURE THE PATIENT WAS COMPLAINING OF LEFT HIP AND LEG PAIN. THE PHYSICIAN BELIEVED THAT THE NEW PAIN WAS PROCEDURE RELATED. THE PATIENT UNDERWENT A LEAD PULL PROCEDURE AND WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48988 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention