BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 8818365 · Received July 23, 2019

    Report

    Report Number
    3004209178-2019-14090
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Date of Event
    September 17, 2018
    Report Date
    February 14, 2020
    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

    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.

    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 STATED THAT THE REASON BEHIND THE IMPEDANCE ISSUE IS STILL UNKNOWN, THE REP WAS CONTINUING TO WORK WITH AND ADJUST THE PATIENT'S STIMULATION. THERE WERE NO PLANS FOR SURGICAL INTERVENTION AT THIS TIME. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FAILED BACK SURGERY SYNDROME AND SPINAL PAIN. INFORMATION WAS REPORTED THAT THE PATIENT HASN'T HAD PAIN RELIEF SINCE BEING IMPLANTED. THUS, THE REP HAS MEET WITH THE PATIENT TO FURTHER PROGRAM TO GET PAIN RELIEF AND TO DETERMINE IF THE LEAD IS AT THE APPROPRIATE LOCATION FOR THERAPY BENEFIT. DURING REPROGRAMMING THE PATIENT HAD NOTICED AN ISSUE WITH IMPEDANCES ON ELECTRODES 3 AND 10, WHICH SHOWED AVOID. COMBINATION OF THE 2 ELECTRODES GAVE 190 OHMS. 3 AND 10 ARE NOT BEING USED IN PROGRAMMING. THE IMPEDANCE READINGS ARE LISTED BELOW: 930 OHMS, 890, 860, 1020, 1050, 1080, 1080, 900 OHMS, 990, 860, 1040, 1020, 1000, 940, 1070 OHMS. NO FURTHER COMPLICATIONS WERE REPORTED. NO PATIENT SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT THERE HAD BEEN NO DETERMINATION OF WHY THERE WERE IMPEDANCE ISSUES. THE REP HAD BEEN PROGRAMMING AROUND IT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613151 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR