BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1864507 · Received October 6, 2010

    Report

    Report Number
    3006630150-2010-01718
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT IS NOT RECEIVING GOOD STIMULATION. DURING A LEAD REVISION PROCEDURE THE PHYSICIAN REPLACED THE PT'S IPG. THE IPG WAS REPLACED BECAUSE WHEN THE PHYSICIAN WENT TO PLUG THE LEADS INTO THE IPG THERE WASN'T A GOOD CONNECTION. THE PT IS DOING WELL FOLLOWING THE REVISION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention