BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1885184 · Received October 25, 2010

    Report

    Report Number
    3006630150-2010-01817
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT THE PT WAS EXPLANTED DUE TO PAIN AT THE INCISION SITE WHERE THE LEAD ANCHORS WERE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention IPG KIT (WITHOUT PULL-THROUGH TUNNELER)| MODEL #: SC-1110-02| MODEL #: SC-2218-50| SERIAL #: 188170| ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014" STYLET| SERIAL #: 242677