BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3882091 · Received June 18, 2014

    Report

    Report Number
    3007566237-2014-01709
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD TWO LAMINECTOMIES AND A ¿THREE LEVEL FUSION¿ AND A STIMULATOR THAT WAS IMPLANTED AND THEN REVISED. IT WAS NOTED THEY HAD RECOMMENDED REMOVING THE STIMULATOR BECAUSE THE PATIENT WAS NOT ABLE TO EMPTY HER BLADDER. IT WAS NOTED THE STIMULATOR WORKED VERY WELL FOR THE PATIENT¿S LEG PAIN BUT NOT BACK, SO THEY REVISED IT AND PUT IN NEW LEADS. IT WAS NOTED THE SURGERY DID NOT GO WELL, AND THE PATIENT HAD DROP FOOT FOR A WHILE, AND NOW COULDN¿T GO TO THE BATHROOM. IT WAS NOTED ¿THEY SAID THAT REMOVING THE STIMULATOR SHOULD HELP THIS.¿ IT WAS NOTED THE PATIENT HAD THE STIMULATOR OFF FOR ALMOST A MONTH AND COULD LIVE WITH THE PAIN, AND IT WAS REPORTED ¿IT SEEMED TO BE MUCH BETTER.¿ THE REPORTER WAS WORRIED ABOUT THE RISKS OF REMOVING THE DEVICE AND WORRIED IT WOULD NOT HELP THE PATIENT¿S BLADDER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358264 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention