BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 8539932 · Received April 23, 2019

    Report

    Report Number
    3004209178-2019-08033
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    March 22, 2018
    Report Date
    May 7, 2019
    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
    MN, 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 BY A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. INFORMATION WAS REPORTED THAT THE PATIENT'S IMPLANT IS HEATING UP, THAT THE SITE IS HOT TO THE TOUCH. THE IMPLANT SITE LOOKS FINE, NO REDNESS OR SWELLING, INS MOVEMENT IS VERY SLIGHT. THE HEALTHCARE PROVIDER (HCP) HAS ALSO EXAMINED THE AREA AND DETERMINED THE SITE IS FINE. THE IMPEDANCE CHECK SHOWED 700-2020 OHMS DEPENDING ON THE ELECTRODE REFERENCE. THE PATIENT SAID SHE HAD A MRI LAST WEEK AND THE SITE SHOWED HEAT PER MRI TECHNICIANS. IT WAS SUGGESTED THAT THE PATIENT TURN THEIR THERAPY OFF, IF POSSIBLE, FOR A DAY OR 2 TO SEE IF THE PATIENT STILL FEELS THE SITE BEING HOT. NO FURTHER COMPLICATIONS WERE REPORTED. NO ADDITIONAL PATIENT SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT THE CAUSE OF THE INS HEATING HAS NOT BEEN DETERMINED. THE PATIENT TRIED TO GO WITHOUT THERAPY IN ORDER TO SEE IF THE INS WOULD NOT BE AS WARM, BUT THE PATIENT WAS UNABLE TO DO SO. THE HEATING HAS NOT BEEN RESOLVED. A ROOT CAUSE OF THE REASON THE INS WAS HEATING WAS NOT DETERMINED AND TECHNICAL SERVICES COULD NOT CONFIRM THERE WAS ANYTHING WRONG WITH THE INS THAT WOULD BE CAUSING THE HEATING. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334089 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR