BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1850882 · Received September 28, 2010

    Report

    Report Number
    3006630150-2010-01662
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 24, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT THE PT HAS DEVELOPED A LESION ABOVE THE IPG SITE WHICH IS OOZING. THE PHYSICIAN DOESN'T KNOW WHY THE SITE IS INFECTED AND PRESCRIBED THE PT ORAL ANTIBIOTICS. THE PT IS DOING WELL FOLLOWING A 10 DAY COURSE OF 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 41 YR Required Intervention SERIAL #: (B)(4)| ARTISAN SURGICAL LD 50CM: MODEL #: SC-8120-50,