BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3051443 · Received April 10, 2013

    Report

    Report Number
    3006630150-2013-00678
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A PERMANENT IMPLANT PROCEDURE, WHILE THE PHYSICIAN WAS TRYING TO INSERT THE LEAD, THE PATIENT LOST MOTOR AND SENSORY NERVE FUNCTIONS ON HIS RIGHT LEG. THE PHYSICIAN BELIEVED THE EVENT WAS PROCEDURE RELATED AND DECIDED NOT TO PROCEED WITH THE IMPLANT. THE PATIENT WAS REPORTEDLY RECOVERING WELL AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153566 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention