BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1760576 · Received July 14, 2010

    Report

    Report Number
    3006630150-2010-01212
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    June 23, 2010
    Report Date
    June 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WILL NOT BE RETURNED TO BSN AS THEY WERE KEPT BY THE PT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT'S PRECISION SYSTEM WAS EXPLANTED DUE TO THE STIMULATION IRRITATING THE PT'S NERVES AND NOT PROVIDING ADEQUATE PAIN RELIEF. THE PT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention LINEAR LEAD, 70 CM WITH PRE-LOADED 0.014" STYLET| (B)(4)| MODEL#: SC-8120-70| MODEL #: SC-2138-70| (B)(4)| (B)(4)| ELECTRODES), 70 CM| ARTISAN 2X8 PADDLE WITH LEAD (WITH SLOTTED