BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 8621205 · Received May 17, 2019

    Report

    Report Number
    3007566237-2019-01090
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    May 11, 2019
    Report Date
    May 17, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED AROUND (B)(6)/(B)(6) 2019, AND IN (B)(6) 2019, THE PATIENT STARTED FEELING INTERMITTENT PULSES/BURSTS OF LIGHT STIMULATION/VIBRATION RISING UP THAT WAS FELT FOR 3-5 SECONDS IN ONE LITTLE AREA "DOWN UNDERNEATH THERE AT THE VERY BOTTOM". THIS WAS OCCURRING EVEN WHEN THEY HAD THE STIMULATION ALL THE WAY DOWN TO ZERO VOLTS BIT WITH THE INS ON. THE PATIENT HAD NOT FELT THIS BEFORE, AND AN INQUIRY WAS MADE AS TO WHETHER OR NOT THIS WAS INDICATIVE OF A DEVICE ISSUE. THE PATIENT WANTED THEIR DEVICE CHECKED AND REQUESTED TO MEET WITH A MANUFACTURER REPRESENTATIVE (REP). IT WAS REVIEWED THAT THE DEVICE WOULD NEED TO BE CHECKED IN PERSON. IT WAS ALSO SUGGESTED THAT THE PATIENT TURN THE INS COMPLETELY OFF AND THEN MONITOR THE SYMPTOMS TO DETERMINE IF THE ISSUE GOES AWAY WHEN IT IS OFF. IT WAS CONFIRMED THAT THE PATIENT WOULD MONITOR THEIR SYMPTOMS AFTER TURNING THE INS OFF AND WOULD FOLLOW UP WITH A DOCTOR IF THE ISSUE DOESN'T RESOLVE. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414133 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 97715

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR