BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3924406 · Received July 9, 2014

    Report

    Report Number
    3006630150-2014-01572
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DEVELOPED A SMALL INFECTION AT THE ANCHOR SITE AFTER A PREVIOUS ANCHOR REVISION PROCEDURE. SYMPTOM INCLUDED HIGH FEVER. IT WAS BELIEVED THAT THE INFECTION WAS PROCEDURE AND DEVICE RELATED. THE PATIENT WAS PRESCRIBED KEFLEX AND THE SITE WAS STITCHED UP AS THE STITCH HAD COME LOOSE. THE INFECTION HAD HEALED AND THE PATIENT WAS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401007 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-4316 15877658

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention