BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1864314 · Received October 7, 2010

    Report

    Report Number
    3006630150-2010-01706
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT THE PT WAS RECEIVING INADEQUATE STIMULATION. X-RAY CONFIRMED LEAD MIGRATION SO THE PHYSICIAN DECIDED TO REVISE. DURING THE REVISION, ONE CONTACT ON THE LEAD DETACHED AND WAS RECOVERED BY THE PHYSICIAN. THE PT WAS REPORTEDLY DOING FINE AFTER THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216=70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention