BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3011838 · Received March 19, 2013

    Report

    Report Number
    3006630150-2013-00503
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    December 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WILL NOT BE REVISED DUE TO A POSSIBLE INFECTION. THE PHYSICIAN BELIEVED THAT THE BURNING SENSATION FELT BY THE PATIENT WAS PROBABLY DUE TO LEAD MIGRATION WHICH WAS CONFIRMED THROUGH CT SCAN. REPROGRAMMING WAS DONE AND THE PATIENT WAS DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT FELT A BURNING SENSATION IN HER LEGS, AND THE PHYSICIAN RECOMMENDED A LEAD REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT FELT A BURNING SENSATION IN HER LEGS, AND THE PHYSICIAN RECOMMENDED A LEAD REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113586 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention