BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 11454672 · Received March 10, 2021

    Report

    Report Number
    3004209178-2021-04038
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    March 2, 2021
    Report Date
    June 1, 2021
    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
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 3777-60 LOT# SERIAL# (B)(6) IMPLANTED: 2011-(B)(6)EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 3777-60 LOT# SERIAL# (B)(6) IMPLANTED: 2011-(B)(6)EXPLANTED: PRODUCT TYPE LEAD MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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 A REP. THE REASON FOR CALL WAS REP. MEETING WITH PATIENT TODAY TO CHECK HER PROGRAMMING AND IMPEDANCE TO MAKE SURE THERE ISN'T A FURTHER ISSUE WITH PATIENT'S SYSTEM. PATIENT MET WITH REP FOR PROGRAMMING IN TENNESEE 4 WEEKS AGO, AND REP NOTED 4 ELECTRODES HAD HIGH IMPEDANCES. IMPEDANCE TODAY HAS GOTTEN WORSE: 0 REFERENCE 1 1070 OHMS 2 1250 3 1270 4 1280 5 1150 6 990 7 1070 8 23580 9 15300 10 34430 11 40K 12 2610 13 3910 14 19930 15 19500 OHMS PATIENT IS PROGRAMMED 0,1,3,4 IN PROGRAM 1 AND PATIENT IS GETTING RELIEF. PROGRAM #2 USES 9,11,12,14 ELECTRODES, TECHNICAL SERVICES(TS) REVIEWED THAT THE 8-15 LEAD ISN'T USABLE. SINCE PATIENT IS GETTING RELIEF WITHOUT IT, PROGRAM#2 CAN BE ELIMINATED, BUT PATIENT HAS ANXIETY ABOUT ANY PROGRAM CHANGES. REP WILL ADD ANOTHER GROUP WITH JUST PROGRAM 1 FOR PATIENT TO USE. PATIENT REPORTS TODAY, THAT SHE FELT SHOCKING SENSATION, THAT'S WHY SHE SAW REP IN TENNESSEE 4 WEEKS AGO, BUT SHOCKING SENSATION WAS NOT REPORTED AT THE TIME UNTIL NOW. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3777-60, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-60, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO TURN UP HER STIMULATION INTENSITY. THE REP PERFORMED AN IMPEDANCE CHECK AND ELECTRODES 8, 10, 13, & 15 WERE OUT OF RANGE. THE REP REPROGRAMMED THE PATIENT USING USABLE ELECTRODES WITH ADEQUATE COVERAGE. THE ISSUE RESOLVED. IT WAS UNKNOWN WHAT FACTORS MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. NO SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351170 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR "SEE H10...."