BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1910750 · Received November 23, 2010

    Report

    Report Number
    3006630150-2010-02036
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PT HAD A SUPERFICIAL INFECTION AT THE POCKET SITE. THE PT'S SYMPTOMS WERE REDNESS AND MINOR DRAINAGE AT THE POCKET SITE. THE PHYSICIAN PRESCRIBED THE PT ORAL ANTIBIOTIC. THE PHYSICIAN DOES NOT BELIEVE THE INFECTION WAS DEVICE OR PROCEDURE RELATED; AS THE PT IS PRONE TO INFECTIONS.

    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 40 YR Required Intervention