BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2902383 · Received January 8, 2013

    Report

    Report Number
    3006630150-2012-02495
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2158-70 SERIAL #: (B)(4), DESCRIPTION: LINEAR LEAD WITH ENHANCED STYLET, 70CM THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE DUE TO PAIN. THE LEADS HAVE MOVED AND LOOPED WHICH HIT A NERVE ROOT CAUSING PAIN. THE OLD LEADS WERE REPLACED WITH NEW ONES. THERE WAS NO DEVICE MALFUNCTION SUSPECTED. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9719 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2158-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention