BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    MDR report key: 3843444 · Received June 2, 2014

    Report

    Report Number
    3007566237-2014-01499
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 977D260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: SCREENING DEVICE; PRODUCT ID 977D260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: SCREENING DEVICE; PRODUCT ID 355531, LOT# N446390, PRODUCT TYPE: SCREENING DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE TRIAL PATIENT HAD PAIN IN THEIR LEFT LEG AND FOOT. IT WAS NOTED THE PATIENT WAS TRANSPORTED TO THE HOSPITAL FOR THE PAIN. IT WAS REPORTED THE PATIENT WAS GIVEN AN MRI, STEROIDS, AND PAIN MEDICATION UPON ARRIVAL. IT WAS NOTED THE PATIENT HAD DISCOMFORT WHEN THE SECOND TRIAL LEAD WAS PLACED. IT WAS REPORTED THAT FLUOROSCOPY SHOWED THE LEAD HAD GONE ANTERIOR, SO THE LEAD WAS REMOVED. IT WAS NOTED THE FIRST LEAD WAS REMOVED DUE TO THE PAIN IN THEIR LEFT LEG AND FOOT. IT WAS REPORTED THE PAIN WAS TOO INTENSE TO REPROGRAM. IT WAS NOTED THERE WAS NO PROBLEMS WITH THE PATIENT¿S TRIAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322090 UNKNOWN EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention