BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    MDR report key: 3150271 · Received June 6, 2013

    Report

    Report Number
    3007566237-2013-01878
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 15, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 387445, LOT# VA06JBY, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: SCREENING DEVICE. (B)(4).

    Description of Event or Problem · 1

    UPON FURTHER REVIEW, THE PATIENT REPORTED ONE DAY AFTER A TRIAL LEAD WAS PLACED, THE PATIENT COMPLAINED OF SEVERE ABDOMINAL AND BACK PAIN WITH AND WITHOUT ANY STIMULATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY AFTER A TRIAL LEAD WAS PLACED, THE PATIENT COMPLAINED OF SEVERE ABDOMINAL AND BACK PAIN. THE PATIENT WAS WITHOUT ANY STIMULATION. THE LEAD WAS REMOVED, BUT THE PAIN DID NOT GO AWAY. THE PATIENT WAS SENT TO THE HOSPITAL VIA AMBULANCE TO RULE OUT EPIDURAL ABSCESS OR A HEMATOMA. IT WAS FURTHER REPORTED THAT THE PATIENT HAD BEEN DISCHARGED FROM THE HOSPITAL AND WAS DOING MUCH BETTER. AN MRI WAS NEGATIVE FOR AN ABSCESS OR HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250649 UNKNOWN EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1