BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 8257185 · Received January 17, 2019

    Report

    Report Number
    3004209178-2019-01199
    Event Type
    Malfunction
    Date Received
    January 17, 2019
    Date of Event
    January 15, 2019
    Report Date
    January 31, 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3998, LOT#: J0406289V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3998, LOT# J0406289V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT OOR (OUT OF REGULATIONS) WAS NOTED AROUND 2MA. IT WAS REPORTED THAT THERE WERE SOME ELEVATED IMPEDANCE MEASUREMENTS FOUND DURING THE IMPEDANCE CHECK. IT WAS NOTED THAT THE REP WAS WITH THE PATIENT TO DO REPROGRAMMING, AND IT WAS THEIR FIRST OPPORTUNITY FOR PROGRAMMING POST IMPLANT IN NOVEMBER. THE REP MENTIONED PREVIOUS APPOINTMENT MEETINGS WITH THE PATIENT, BUT INDICATED THAT THEY DID MORE IN REGARDS TO RECHARGE EDUCATION THAN WITH PROGRAMMING AS THE PATIENT¿S INS WAS NOT CHARGED. IT WAS REPORTED THAT THE OOR HAD A PROGRAMMING WITH FIVE ELECTRODES. IT WAS REVIEWED DOING IMPEDANCES WITH EVERY REFERENCE. IT WAS STATED THAT SOME MEASUREMENTS TAKEN INCLUDED REFERENCE 0 AND IT WAS SUGGESTED WRITING DOWN ALL COMBOS THAT WERE UNDER 2,000 OHMS (SUCH AS 01 AND 04) 01= 670 02= 2770 03= 4250 04 1350 05 7130 06 9130 07 10640 REF 3 0 2770 2 2660 THE CALLER WAS ADVISED TO REPROGRAM USING COMBINATIONS WITHIN RANGE AND REMOVE ALL ELEVATED ELECTRODES. IT WAS REPORTED THAT THE EVENT OCCURRED ON (B)(6) 2019. IT WAS NOTED THAT SINCE IMPLANT THE PATIENT HAD NOT HAD STIMULATION, BUT WAS NOT PROGRAMMED TO THE PATIENT¿S NEEDS, AS THE PATIENT¿S PREVIOUS IMPLANT SETTINGS WERE UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REPORTING THAT REPROGRAMMING AROUND THE ELEVATED ELECTRODES WORKED TO PROVIDE STIMULATION, HOWEVER THE PATIENT WAS NOT GETTING STIMULATION WHERE THEY WANTED IT. AT THIS POINT THE REP STATED THAT THEY WERE UNSURE IF THE PATIENT EVER RECEIVED STIMULATION WHERE THEY CURRENTLY WERE EXPECTING IT. THE PATIENT WAS UNABLE TO RECALL SPECIFIC AREAS THAT WERE COVERED/HELPED BY THE STIMULATION WITH THEIR PREVIOUS DEVICE. THE CAUSE OF THE ELEVATED/HIGH IMPEDANCES WERE UNKNOWN. THE PATIENT¿S WEIGHT AT THE TIME OF THE REPORT WAS UNKNOWN. IT WAS INDICATED THAT THE PROVIDED INFORMATION HAD BEEN CONFIRMED WITH THE PHYSICIAN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51360 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR