BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1901549 · Received November 12, 2010

    Report

    Report Number
    3006630150-2010-01900
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S WOUND WAS NOT CLOSING. THE PHYSICIAN ELECTED TO REPLACE THE IPG. THE PHYSICIAN DID NOT FEEL THE PATIENT'S CONDITION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS GIVEN ORAL AND IV ANTIBIOTICS AND WAS REPORTEDLY DOING WELL.

    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 27 YR Required Intervention