BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 8355716 · Received February 20, 2019

    Report

    Report Number
    3004209178-2019-03633
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    November 1, 2018
    Report Date
    April 5, 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
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 97745 SERIAL# (B)(4) PRODUCT TYPE PROGRAMMER, PATIENT. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT REPORTING THAT THEY HAD CALLED IN PREVIOUSLY REGARDING CONTROLLER ISSUES AND THE PATIENT STATED THAT THEY WERE SCHEDULED TO MEET WITH A MANUFACTURER REPRESENTATIVE (REP) ON (B)(6), BUT THAT THEY HAD TO RESCHEDULE. AN EMAIL WAS SENT OUT TO THE REP REGARDING THE PATIENT WANTING TO RESCHEDULE AND A RESPONSE WAS RECEIVED THE SAME DAY FROM THE REP INDICATING THAT THEY WERE ABLE TO RESCHEDULE WITH THE PATIENT FOR (B)(6). NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97745, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. 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 REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. THE PATIENT WAS CALLING IN BECAUSE THEY DIDN¿T KNOW HOW TO USE THEIR CONTROLLER AND THEIR DOCTOR¿S OFFICE TOLD THEM TO CALL THE MANUFACTURER AND HAVE A MANUFACTURER REPRESENTATIVE (REP) GO TO THEIR HOUSE AND GIVE THEM INSTRUCTIONS. THE REP¿S ROLE WAS REVIEWED. THE PATIENT REPORTED THAT THEY DIDN¿T THINK THEIR STIMULATION WAS WORKING AND THEY DIDN¿T KNOW HOW TO USE THEIR CONTROLLER. IT WAS UNKNOWN IF THE PATIENT HAD HAD ANY RECENT EMI EXPOSURE, BUT THE PATIENT STATED THAT THEY HAD HAD TWO SURGERIES (UNRELATED TO THEIR DEVICE/THERAPY) RECENTLY. ON THE CALL THE PATIENT WAS ABLE TO ¿USE THE CONTROLLER AND UNLOCK¿ AND WAS ABLE TO GET THE SCREEN ¿SEARCHING FOR DEVICE¿. THE PATIENT STATED THAT THEY HADN¿T FELT STIMULATION SINCE (B)(6) 2018. THE PATIENT WASN¿T SURE IF THEY HAD CHARGED THE INS THE WAY THEY WERE SUPPOSED TO. THE PATIENT DID NOT WANT TO CONTINUE TO TROUBLESHOOT OVER THE PHONE AS THEIR LEFT ARM WAS SORE FROM AN UNRELATED SURGERY. THE PATIENT STATED THAT THEY DID NOT HAVE ANYONE THAT WAS ABLE TO ASSIST THEM AND WOULD RATHER MEET WITH A REP. AT ON POINT DURING THE CALL THE PATIENT STATED THAT THEY GOT THE SCREEN SHOWING OPTIONS OF STIMULATION ON/STIMULATION OFF AND THE PATIENT PRESSED THE STIMULATION ON AND THE CONTROLLER TURNED OFF. THEY WERE REDIRECTED TO THEIR HEALTHCARE PROVIDER (HCP) TO GET IN CONTACT WITH A REP. AN EMAIL WAS ALSO SENT TO THE LOCAL REP TO REACH OUT TO THE PATIENT. IT WAS ASKED BUT WAS UNKNOWN IF THE CHANGE IN THERAPY/SYMPTOMS WERE CONSIDERED TO BE SUDDEN OR GRADUAL. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A REPRESENTATIVE WHO MET WITH THE PATIENT. IT WAS CONFIRMED THAT THE DEVICE WAS FUNCTIONING WITHOUT ISSUES. THE PATIENT NEEDED A RECHARGE AND A PATIENT PROGRAMMER. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148344 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR