BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2842052 · Received November 21, 2012

    Report

    Report Number
    3007566237-2012-02806
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 22, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT AFTER SURGERY FOR A REPLACEMENT IMPLANTABLE NEUROSTIMULATOR, THE PATIENT GOT A STAPH INFECTION. THE PATIENT WAS IN THE HOSPITAL FOR 10 DAYS AND WAS ADMINISTERED IV MEDICATIONS. IT WAS STATED THAT THE PATIENT WAS HURTING SO BADLY "SHE COULDN'T MOVE." PATIENT HAD TO HAVE SURGERY AGAIN. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R