BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3200474 · Received July 1, 2013

    Report

    Report Number
    3006630150-2013-01360
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A REVISION PROCEDURE, AFTER THE PHYSICIAN OPENED THE POCKET, THE PHYSICIAN NOTED A SUSPICIOUS CLOUDY FLUID AROUND THE IPG. THE PHYSICIAN ENDED UP EXPLANTING THE DEVICE. THE PATIENT WAS GIVEN ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298221 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention