BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 10317228 · Received July 23, 2020

    Report

    Report Number
    3004209178-2020-12736
    Event Type
    Malfunction
    Date Received
    July 23, 2020
    Date of Event
    March 23, 2020
    Report Date
    July 27, 2020
    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
    CA, US
    Reporter Occupation
    003

    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

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT COULD NOT INCREASE THE INTENSITY ON PROGRAM A4. 4. THE PATIENT HAS THREE GROUPS BUT ONLY HAS TRIED USING GROUP A. THE REP RAN IMPEDANCES AND FOUND ELECTRODE 8 SHOWED THE DO NOT USE INDICATOR AND HIGH IMPEDANCE VALUE. SHE REMOVED ELECTRODE 8 FROM THE PROGRAMMED PARAMETERS AND WHEN SHE ENDED THE SESSION THE PATIENT WAS STILL UNABLE TO INCREASE THE INTENSITY ON PROGRAM A4. THE PATIENT IS PROGRAMMED WITH THE FOLLOWING PARAMETERS. A1: 12- 13+ PULSE WIDTH (PW) 450US 60HZ AMP, A2: 9 10 11 PW 90US 60HZ AMP: 2.4MA, A3 4 7 12 PW: 90US 60HZ AMP: 0MA, A4 0 2 PW 460US 60HZ AMP: 3.6MA. THE REP INCREASED THE INTENSITY ON PROGRAM A4 UP TO 3.6 AND THE PATIENT WAS FEELING STRONG STIM, BUT THE TABLET WAS NOT DISPLAYING THE OOR MESSAGE. THE PATIENT INDICATED THAT HE WAS LIMITED AROUND 3.2MA WITH THE PATIENT CONTROLLER. THE REP RAN IMPEDANCES AND PROVIDED THE FOLLOWING VALUES: REF 0 2 1080OHMS, REF 4 7 1110OHMS 10 1020OHMS, REF 9 10 800 11 860OHMS. WHILE REVIEWING THE IMPEDANCES THE CALLER INDICATED THAT TABLET DISPLAYED AN ALERT THAT PROGRAM 4 IS IN OOR. THE CALLER RERAN IMPEDANCES AND GOT SIMILAR VALUES: REF 0 2 1070OHMS ALL VALUES OTHER THAN 8 ARE IN THE 900-1100OHM RANGE, REF 2 ALL VALUES IN THE 1000OHM RANGE. THE REP WILL CONTINUE PROGRAMMING WITH THE PATIENT. NO SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE (REP) INDICATED THAT THE CAUSE OF THE HIGH IMPEDANCE WAS UNKNOWN. THEY STATED THAT THEY PROGRAMMED AROUND ONLY ELECTRODE SHOWING HIGH IMPEDANCE, BUT THERE IS STILL OUT OF RANGE. THE ISSUE WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781569 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR