BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 7999252 · Received October 24, 2018

    Report

    Report Number
    3004209178-2018-23768
    Event Type
    Injury
    Date Received
    October 24, 2018
    Date of Event
    October 22, 2018
    Report Date
    December 12, 2018
    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 · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) ON 2018-OCT-25. IT WAS REPORTED THAT THE CAUSE OF THE HIGH IMPEDANCES WAS NOT DETERMINED. TO RESOLVE THE ISSUE, THE REP USED ONLY THE ELECTRODES THAT HAD SATISFACTORY IMPEDANCES. THEY ALSO TRIED DIFFERENT PULSE WIDTHS AND RATES, BUT THE HIGH IMPEDANCES WERE NOT RESOLVED, AND THE PATIENT¿S THERAPY WAS VERY LIMITED AT THIS TIME. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2018, PRODUCT TYPE LEAD. 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

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE PATIENT HAD A SUCCESSFUL LEAD REVISION ON (B)(6) 2018. THE PATIENT CONFIRMED GOOD THERAPY WHICH COVERED HIS PAIN AREAS IN THE PACU. THE REP NOTED THAT THE PATIENT MENTIONED ONLY GETTING THERAPY FOR A HALF DAY BUT WAS UNSURE EXACTLY WHAT THAT MEANT. THE PATIENT DID NOT CHARGE SO IMPEDANCES COULD NOT BE CHECKED PRIOR TO REVISION. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT AN OUT OF REGULATION (OOR) MESSAGE WAS SEEN ON THE CLINICIAN TABLET. THE REP REPORTED THE PATIENT IS NOT ABLE TO GET ABOVE 2 MA. IMPEDANCES SHOWED 0 - 3850 OHMS, 1 - 3850, 2 - 10810, 3 - 11690, 4 - 3270, 5 - 4300, 6 - 10510, 7 - 18830, 8 - 40K, 9 - 33600, 10 - 40K, 11 - 32600, 12 - 31300, 13 - 10420, 14 - 40K, AND 15- 10710 OHMS. THE REP DIDN'T HAVE IMPEDANCE HISTORY. THE REP SAID THE PATIENT WAS GETTING STIMULATION WITH THE PREVIOUS SYSTEM AROUND 3 VOLTS. IT WAS REVIEWED THAT HIGH IMPEDANCE ARE AFFECTING THE THERAPY DELIVERY. IT WAS SUGGESTED THE REP USE ELECTRODES 0, 1, 4, AND 5 WITH HIGH PULSE WIDTH AND THE REP WAS ABLE TO GET TO 2.4 MA, BUT THE PATIENT STILL CAN'T FEEL STIMULATION. IT WAS RECOMMENDED AN X-RAY BE TAKEN TO CHECK LEAD POSITION TO COMPARE TO THE PREVIOUS INS. THE REP WAS GOING TO CONSULT WITH THE HCP. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841172 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention