BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2991799 · Received March 6, 2013

    Report

    Report Number
    3006630150-2013-00384
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING A HEMATOMA AROUND THE POCKET SITE. THE PHYSICIAN BELIEVES THE HEMATOMA WAS PROCEDURE RELATED. THE PATIENT WAS ADMITTED AT THE HOSPITAL AND UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE. THE PATIENT WAS DOING WELL POST-OPERATIVELY AND WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96027 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R