BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 9824508 · Received March 12, 2020

    Report

    Report Number
    3004209178-2020-05238
    Event Type
    Malfunction
    Date Received
    March 12, 2020
    Date of Event
    January 28, 2020
    Report Date
    April 16, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 PATIENT REGARDING THEIR IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT PATIENT CHARGES HIS IMPLANT EVERY EVENING BEFORE GOING TO BED, HE WAKES UP IN THE MORNING AND HIS BACK IS STIFF AND HE USES THE CONTROLLER TO CHECK IMPLANT AND CONTROLLER SHOWS THE IMPLANT IS OFF. PATIENT STATES THIS HAS BEEN HAPPENING SINCE (B)(6) 2020 AND TWICE A WEEK AND HE HAS BEEN RESETTING THE CONTROLLER AND THAT DOESN'T HELP. DEVICE FUNCTIONALITY WAS REVIEWED WITH THE CALLER AND RECOMMEND PATIENT AND HIS WIFE MONITOR THE BATTERY LEVEL AND THERAPY ON/OFF AND CONSULT WITH HCP OFFICE FOR NEXT STEPS. PATIENT'S WIFE STATED THE CONTROLLER WAS 70% AND INS WAS 100% AT THE TIME OF THE CALL. NO FURTHER COMPLICATIONS WERE REPORTED. **OMITTED INFORMATION REGARDING "PATIENT STATES HE RECEIVED A ANOTHER CONTROLLER 6 MONTHS AGO SEE PRIOR CRTS 3850776/PE 702540315 (NNI).**

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. IT WAS REPORTED THAT 3 OR 5 TIMES A WEEK IT WILL SHUT DOWN DURING. PATIENT DID NOT KNOW IF THE ISSUE HAD RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286437 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR