BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 10706249 · Received October 20, 2020

    Report

    Report Number
    3004209178-2020-18321
    Event Type
    Injury
    Date Received
    October 20, 2020
    Date of Event
    July 12, 2018
    Report Date
    October 20, 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
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97745, SERIAL: (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED VIA A MANUFACTURER REPRESENTATIVE FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THERE WAS A RECHARGING ISSUE AND DIFFICULTY WITH RECHARGING. THE PATIENT REPORTS EXCELLENT COUPLING, BUT IT IS TAKING A LONG TIME TO RECHARGE. ON (B)(6) 2018, THE PATIENT RECHARGED TWICE, ONCE FOR 1.2 HOURS AND ONCE FOR 2.2 HOURS, AND SHE HAD STARTED AT 10% CHARGE. THE DIARIES SHOW THAT RECHARGING IS FAIR. BASED ON THE TIME OF CHARGE, THE DIARIES DATA IS CORRECT WITH THE PATIENT¿S COUPLING BEING ¿FAIR.¿ IT WAS REVIEWED THAT THE PATIENT SHOULD MONITOR TO MAKE SURE THAT THE IMPLANTABLE NEUROSTIMULATOR RECHARGER DOES NOT MOVE DURING RECHARGING. THE MANUFACTURER REPRESENTATIVE WAS ABLE TO GET GOOD COUPLING. THE PATIENT IS SEEING THE ¿FINISHED¿ SCREEN AT 80% BATTERY CHARGED. IT WAS REVIEWED THAT AT ANY PERCENTAGE WHEN RECHARGING HAS STOPPED, THE SCREEN WILL DISPLAY ¿FINISHED.¿ THESE RECHARGING ISSUES HAD BEEN OCCURRING SINCE IMPLANT. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) VIA THE PATIENT ON (B)(6) 2019. THE PATIENT DOESN'T HAVE PAIN WHEN THE STIMULATION IS OFF AND CHARGING IS A BURDEN TO GET A GOOD SIGNAL SO THEY WANT THE STIMULATOR EXPLANTED. THERE WERE UNKNOWN FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PATIENT IS ADAMANT ABOUT GETTING IT REMOVED AND DOESN'T WANT TO TRY ANYTHING ELSE. THE REP TOLD THE PATIENT TO CALL THEIR PHYSICIAN TO DISCUSS. IT WAS UNKNOWN IF ANYTHING WAS DONE AT THIS TIME. THE ISSUE WAS NOT RESOLVED BUT THE PATIENT WAS NOTED TO BE ALIVE WITH NO INJURY. THE PATIENT REPORTED THAT SHE HAD THE SYSTEM REMOVED BECAUSE SHE WAS HAVING SO MUCH PROBLEMS WITH IT. SHE HAD TO SIT 2-3 HOURS A DAY TO RECHARGE IT AND IT DID NOT HELP HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171504 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention