BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 5995244 · Received October 3, 2016

    Report

    Report Number
    3004209178-2016-20297
    Event Type
    Injury
    Date Received
    October 3, 2016
    Date of Event
    January 1, 2014
    Report Date
    October 3, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THEY DID NOT GET ANY RELIEF FROM THE STIMULATOR. IT WAS REPORTED THAT EVERYTHING WENT DOWNHILL. THEY HAD AN INFECTION "DISCITIS" AND HAD TO REMOVE THEIR IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM ON (B)(6) 2016 IN ORDER TO DO AN MRI. THE CONSUMER BELIEVED THAT THE INFECTION WAS RELATED TO THEIR DEVICE OR THERAPY. THERE WAS A REPORT OF A CONFIRMED INFECTION AND NO RELIEF FROM THE INS OCCURRED IN 2014. RELEVANT MEDICAL HISTORY INCLUDES FAILED BACK SURGERY SYNDROME AND CHRONIC LOW BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646852 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention