BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 9348893 · Received November 20, 2019

    Report

    Report Number
    3004209178-2019-22229
    Event Type
    Malfunction
    Date Received
    November 20, 2019
    Date of Event
    November 18, 2019
    Report Date
    December 13, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    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

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE CAUSE WAS NEVER DETERMINED. THE IMPEDANCES ENDED UP SETTLING DOWN 3-4 HOURS POST-OP. TIME AND THE PATIENT SITTING UPRIGHT RESOLVED THE ISSUE. ALL ELECTRODES WERE RESOLVED EXCEPT ONE TO TWO WERE SHOWING AVOID. THIS WAS 2 OUT OF 8 ELECTRODES THAT INITIALLY WERE HAVING ISSUES. THE PATIENT WAS BEING SENT HOME FROM SURGERY, SO THEY DIDN'T GET TO SIT AROUND AND WAIT FOR THOSE TO RESOLVE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. THE REP REPORTED THAT THERE WERE HIGH IMPEDANCES IN RECOVERY AFTER PLACEMENT. THE REP RAN IMPEDANCES AND CONNECTIVITY INTRA-OPERATIVE AND ALL INDICATORS WERE GREEN AND IMPEDANCES WERE BELOW 1,000 OHMS. THE REP REPORTED THAT JUST PRIOR TO CALLING, THE PATIENT WAS IN RECOVERY AND THE REP WAS MEASURING IMPEDANCES. THE REP REPORTED THAT IMPEDANCES WERE FLUCTUATING WITH DIFFERENT VALUES BEING OUT OF RANGE. THE REP REPORTED THAT SOME OF THE INDICATORS WERE RED AND THE RED INDICATORS WERE CHANGING FROM IMPEDANCE TEST TO IMPEDANCE TEST. THE REP PROVIDED THE FOLLOWING IMPEDANCE RESULTS FROM THE MOST RECENT TEST: REF 0 5 6 7 8 >40000 11 40000 13 40000 REF 8 0 1 11700 2 40000 3 2540 4 2690 5 40000 6 40000 7 40000 9 1360 10 1450 11 40000 12 40000 13 40000 14 1290 15 1390. THE REP REVIEWED THE FOLLOWING IMPEDANCE INFORMATION FROM THE INTRO-OPERATIVE REPORT: REF 8 0 830 1 820 2 790 3 760 4 870 5 890 6 850 7 830 9 800 10 860 11 1040 12 1000 13 800 14 770 15 920. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143860 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR