BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 5268552 · Received December 4, 2015

    Report

    Report Number
    3004209178-2015-23853
    Event Type
    Malfunction
    Date Received
    December 4, 2015
    Report Date
    November 6, 2015
    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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3487A-33, LOT# V072248, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4)

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR NON-MALIGNANT PAIN. IT WAS REPORTED THERE WAS OVERSTIMULATION. THE PATIENT FELL AND HIT HER BACK ON HER DRESSER AND THE "AREA ITSELF SEEMED TO BE MOVED OUT OF POSITION." THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) DID NOT SEEM TO BE WORKING PROPERLY. IT SEEMED LIKE SOMETIMES, WHEN THE PATIENT LAID IN CERTAIN POSITIONS, THE INS GOT STRONGER OR WEAKER FOR NO REASON. THE PATIENT NOTED THIS OCCURRED WITHOUT THE HER TOUCHING HER CONTROLLER OR MAKING ANY CHANGES. NO INTERVENTIONS OR OUTCOMES WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798519 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 00041 YR