BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1962761 · Received January 13, 2011

    Report

    Report Number
    3006630150-2011-00044
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT HAS DRAINAGE FROM THE MIDLINE INCISION AND THAT THE WOUND OPENED UP AND THE LEAD WAS VISIBLE. THE PHYSICIAN MADE A SMALL INCISION AT THE MIDLINE AND RE-SEWED IT BACK TOGETHER. 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-8216-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention