BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 7443768 · Received April 19, 2018

    Report

    Report Number
    3007566237-2018-01156
    Event Type
    Malfunction
    Date Received
    April 19, 2018
    Date of Event
    April 16, 2018
    Report Date
    April 19, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    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 REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS). IT WAS REPORTED THAT AS SOON AS THE REP WOULD SYNC WITH THE CONTROLLER, WITH SETTINGS AT 3.5 MA AND 5.8 MA, THEY WOULD SEE ¿CANNOT GET DESIRED SETTINGS.¿ THE REP REPORTED THAT CONTACTS 2/10 HAD IMPEDANCES GREATER THAN 40000 OHMS. THE REP STATED THAT THE PATIENT WAS PROGRAMMED ON 2/10, BUT HAD CHANGED THAT TO ¿5, 6, 7, AND 13, 14, 15.¿ THE REP WAS UNAWARE OF ANY EVENT THAT PROMPTED THE ISSUE. THE REP REPORTED THE FOLLOWING INFORMATION ABOUT THE REFERENCE ELECTRODES: REF: 5/6-1050. REF: 6/7-1050 OHMS. REF: 5/7 1110 OHMS. REF: ALL CONTACTS >40K OHMS. REF: 13/15-1010 OHMS. THEY COULD NOT TROUBLESHOOT DUE TO LACK OF ACCESS TO THE PRODUCT. THE REP WAS GOING TO TRY REMOVING CONTACT 14 AND SEE IF THEY COULD GET A HIGHER INTENSITY VALUE. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED. FOLLOW UP WAS CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287707 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 97715

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR