BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    MDR report key: 3267566 · Received August 6, 2013

    Report

    Report Number
    3007566237-2013-02600
    Event Type
    Injury
    Date Received
    August 6, 2013
    Date of Event
    July 12, 2013
    Report Date
    July 13, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 387360, LOT# V950561, PRODUCT TYPE SCREENING DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A WET TAP DURING THE TRIAL AND THE HCP ADMINISTERED A BLOOD PATCH.THE PATIENT REPORTED A HEADACHE WHEN UPRIGHT AFTER THE TRIAL AND WENT TO THE EMERGENCY ROOM. THE HCP INSTRUCTED THE PATIENT TO REMAIN IN A LYING POSITION AS MUCH AS POSSIBLE. THE HCP MADE PLANS TO SEE THE PATIENT AGAIN AND WAS CONSIDERING ANOTHER BLOOD PATCH. IT WAS NOTED THAT STIMULATION MADE THE PATIENT NAUSEOUS AT THIS TIME. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS REPORTED AS ALIVE WITH NO INJURY. IT WAS LATER REPORTED THAT THE LEAD WAS PULLED. THE PATIENT WAS NOT PROCEEDING WITH IMPLANT AND IT WAS REPORTED THAT THERE WERE NO FURTHER UPDATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367634 UNKNOWN EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention