BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 8433409 · Received March 19, 2019

    Report

    Report Number
    3004209178-2019-05596
    Event Type
    Malfunction
    Date Received
    March 19, 2019
    Date of Event
    January 1, 2019
    Report Date
    March 19, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    UDI-DI
    00613994610430
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    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 PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT REPORTED THAT THE THERAPY WAS TURNING OFF BY ITSELF. THE PATIENT REPORTED THAT HE WASN¿T SURE IF THE IMPLANT HAD GONE BAD BECAUSE THE IMPLANT WAS SOMETIMES SHUTTING ITSELF OFF AND HE¿D LIKE TO HAVE A MANUFACTURER¿S REPRESENTATIVE (REP) MEET HIM AT HIS HEALTHCARE PROVIDER¿S OFFICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225642 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714 00613994610430

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR