BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2921308 · Received January 17, 2013

    Report

    Report Number
    3006630150-2013-00070
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #SC-2218-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT POCKET REVISION DUE TO POCKET DISCOMFORT. THE PATIENT ALSO UNDERWENT LEAD REVISION WHERE THE PHYSICIAN ADDED NEW PERCUTANEOUS LEAD ON THE RIGHT SIDE, THE OTHER LEAD WAS MOVED TO THE LOWER LEFT BACK DUE TO DISCOMFORT FELT BY THE PATIENT ON THE UPPER RIGHT BACK. THE PATIENT WAS DOING FINE FOLLOWING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27036 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention