BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2874494 · Received December 14, 2012

    Report

    Report Number
    3006630150-2012-02403
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 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
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT CAUSED BY THE CLIK ANCHOR. THE PATIENT UNDERWENT AN ANCHOR REVISION WHEREIN THE PHYSICIAN BACKED UP THE SET SCREW TOO FAR AND THE SCREW CAME OUT OF THE CLIK ANCHOR. THE PHYSICIAN LEFT THE CLIK ANCHOR IMPLANTED AND ADDED A 1 CM SILICON ANCHOR. THE PATIENT WAS REPORTEDLY DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-4316 15238582

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention