BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 8054619 · Received November 9, 2018

    Report

    Report Number
    3004209178-2018-25064
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Date of Event
    October 30, 2018
    Report Date
    November 9, 2018
    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.

    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 THERE WERE POST-OP HIGH IMPEDANCES. THE PATIENT WAS STILL IN SURGERY, BUT CLOSED AND THE INCISION WAS BEING DRESSED. THE REP STATED THAT INTRA-OP IMPEDANCES WERE MEASURING GOOD ON A CONNECTION CHECK AND IMPEDANCE TESTS. AT THE POINT OF CLOSING, THEY MEASURED AGAIN AND FOUND ELECTRODE 7 TO BE >40,000 OHMS AND CONFIRMED IT WAS MARKED AS 'RED'; THE REP ALSO CONFIRMED OTHER MEASUREMENTS WERE IN THE 3000 RANGE. THE REP WAS DIRECTED TO TEST AGAIN OR APPLY STIMULATION TO THE PATIENT FOR SEVERAL MINUTES TO SEE IF MORE IN RANGE MEASUREMENTS COULD BE OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. IT WAS REPORTED THAT THE CAUSE WAS NOT KNOWN. PATIENT WAS GOING TO BE SEEN AGAIN ON 11/6. PATIENT'S WEIGHT WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. IT WAS REPORTED THAT ELECTRODE 7 WAS RED ON LEAD CONNECTIONS, THEREFORE A >40,000 READING. EVERYTHING ELSE WAS GREEN BUT WITH HIGHER NUMBERS ON BOTH LEADS (2000,3000). THE REP SAID THE ODD THING ABOUT ELECTRODE 7 BEING RED WAS WHEN LEAD SELECT AND IMPEDANCES WERE DONE INTRA-OP, ALL WERE GREEN THEN POST-OP THEY WERE RED AND 7 LEAD SELECT WAS RED AND >40,000. THE CAUSE WAS UNKNOWN AS TO WHY THIS HAPPENED AND THAT WAS WHY THE REP CALLED, TO HELP FIGURE IT OUT. ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE ISSUE WERE THAT THEY USED 8-15 LEAD 1000/200 AND CYCLED BECAUSE CHARGING INTERVAL OTHERWISE WAS .5 DAYS; WITH CYCLING IT WAS 1.5 DAYS. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895814 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR