BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 7388490 · Received April 2, 2018

    Report

    Report Number
    3004209178-2018-06196
    Event Type
    Malfunction
    Date Received
    April 2, 2018
    Date of Event
    January 1, 2018
    Report Date
    May 2, 2018
    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
    OH, US
    Reporter Occupation
    OTHER

    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 PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF LUMBAR RADICULOPATHY AND SPIN AL PAIN. IT WAS REPORTED THAT THE PATIENT¿S STIMULATION WAS TURNING OFF BY ITSELF. THE PATIENT REPORTED THAT THE STIMULATION WAS DROPPING/DECREASING FROM WHERE THEY WANT IT WHEN THEY LAY DOWN. IT WAS NOTED THAT THE THERAPY WAS TURNED ON AND ADAPTIVE STIMULATION WAS ENABLED. THE PATIENT WAS INSTRUCTED TO LAY DOWN, SET THE STIMULATION TO THE DESIRED INTENSITY, AND THEN MAINTAIN THE POSITION FOR 3 MINUTES OR LONGER. THE PATIENT REPORTED THAT THE STIMULATION WAS TOO STRONG AND THEY DECREASED IT TO 5.20V. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING THE PATIENT. IT WAS REPORTED THAT THE CAUSE OF THE STIMULATION DECREASING WHEN THE PATIENT WAS LAYING DOWN WAS THAT THEY NEEDED TO SET IT HIGHER THAN IT HAD BEEN. THE PATIENT STATED THAT THEY NEEDED TO LAY STILL FOR FOUR MINUTES TO SET IT. THEY STATED THAT THE STIMULATION DECREASING WHEN LAYING DOWN HAD BEEN RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231600 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 74 YR