BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 9638958 · Received January 28, 2020

    Report

    Report Number
    3004209178-2020-02028
    Event Type
    Malfunction
    Date Received
    January 28, 2020
    Report Date
    March 10, 2020
    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
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. THE PATIENT SAID IF SHE DOESN'T TURN STIMULATION OFF PRIOR TO LAYING BACK FOR CERTAIN PROCEDURES IT FEELS LIKE SHE IS LAYING BACK IN AN ELECTRIC CHAIR. AN EXAMPLE PROVIDED WAS LAYING BACK IN A CHAIR AT THE DENTIST WITHOUT TURNING STIMULATION OFF. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98952 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