BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 9444686 · Received December 10, 2019

    Report

    Report Number
    3004209178-2019-23478
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    October 15, 2019
    Report Date
    December 10, 2019
    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
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    (B)(6) 2019 CRTS 3945186 (CON): *** OMITTED INFORMATION REGARDING 703497977 LOW INS MSG,READING ISSUE*** INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE THERAPY DIDN¿T WORK FOR THE PATIENT. THEY HAD FIVE PROGRAMS AND THE PATIENT EITHER FELT NOTHING OR THE IMPLANTABLE NEUROSTIMULATOR (INS) ¿SHOCKED THE HELL OUT OF HER. THE PATIENT STATED THAT SHE WAS GETTING NO PAIN RELIEF AND THE TRIAL WAS VERY SUCCESSFUL, BUT SINCE SHE¿S HAD THE INS, SHE'S HAD TERRIBLE ISSUES WITH RESTLESS LEG SYNDROME. IT WAS ALSO REPORTED THAT THE PATIENT¿S PAIN WAS THE SAME, IF NOT WORSE THAN AFTER THE TRIAL. THE PATIENT ALSO STATED THAT THEIR HEALTHCARE PROFESSIONAL (HCP) WOULDN¿T PRESCRIBE THEM MEDICATION AND THE HCP HASN¿T ¿GIVEN A CRAP¿ ABOUT THEM. THE PATIENT HAD BEEN REPROGRAMMED FIVE TIMES AND THE LEAD WAS IN THE CORRECT SPOT. AT THE TIME OF THE CALL, THE STIMULATION WAS TURNED OFF BECAUSE IT WAS SHOCKING HER AND WHEN THE PATIENT GOT OUT THEIR CONTROLLER, THEY NOTED THAT SHE TURNS S TIM OFF BECAUSE ANY OTHER SETTING WOULD SHOCK HER. IN THE END, THE PATIENT WAS REDIRECTED TO FOLLOW-UP WITH THEIR HEALTHCARE PROFESSIONAL (HCP) TO CONTINUE WORKING ON THE THERAPY ISSUE AND KEEP STIM OFF. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED. (B)(6) 2019 _E1 (HCP, REP): ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP WHO REPORTED THEY CONFIRMED THE INFORMATION WITH THE DOCTOR. THEY REPORTED THEY WERE NOT MADE AWARE OF A SHOCKING ISSUE. THEY WERE STILL ATTEMPTING TO OPTIMIZE THE PATIENT'S THERAPY AFTER THE IMPLANT, BUT THE PATIENT WAS UNWILLING TO COOPERATE WITH THE GUIDANCE PROVIDED BY THE REP AND THE DOCTOR NOR WERE THEY UTILIZING THE THERAPY CONSISTENTLY. THE PATIENT HAD MET WITH THE REP TWO TIMES, AND THE REP REPORTED THEY PROVIDED GUIDANCE AND EDUCATION TO THE PATIENT BOTH TIMES. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242568 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR