BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1833426 · Received September 9, 2010

    Report

    Report Number
    3006630150-2010-01497
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 11, 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
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG POCKET WAS INFECTED. THE SURGEON WASHED OUT THE POCKET AND LEAD SITE INCISION SITES WITH ANTIBIOTIC SOLUTION. THE PATIENT HAD TAKEN SOME ORAL ANTIBIOTICS SINCE BEING IMPLANTED AND WAS NOT GIVEN ANY AFTER THE WOUND WAS FLUSHED OUT. THE PATIENT WAS DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention 50 CM, MODEL # - SC-8120-50| ARTISAN 2X8 PADDLE LEAD (WITH SLOTTED ELECTRODES)| SERIAL # - (B)(4)