BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1864320 · Received October 7, 2010

    Report

    Report Number
    3006630150-2010-01711
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT THE PT WAS EXPLANTED DUE TO AN INFECTION. THE PHYSICIAN REPLACED THE PT'S IPG AND LEAD, ALTHOUGH, THERE WAS NOTHING WRONG WITH THE DEVICES. THE PT POCKET SITE WAS ALSO MOVED TO THE RIGHT SIDE AND THE PT WAS PRESCRIBED ORAL ANTIBIOTICS.

    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 31 YR Required Intervention ARTISAN 2X8 PADDLE LEAD (LIM), 50 CM| MODEL#: SC-8216-50| SERIAL #: (B)(4)