BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 18641986 · Received February 5, 2024

    Report

    Report Number
    3004209178-2024-03592
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Date of Event
    September 15, 2021
    Report Date
    February 5, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781740
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REGULATORY REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AS PART OF REMEDIATION PLAN 411 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

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. THE REASON FOR CALL WAS REP REPORTS THAT THE PATIENT WAS GETTING SETTINGS NOT AVAILABLE SINCE ABOUT 2 WEEKS AGO.  IMPEDANCE CHECK SHOWED:1 40K OHMS, 2 1400, 3 1360, 4 1940, 5 40K, 6 40K, 7 40K, 8 1570, 9 2040, 10 1770, 11 1580, 12 1380, 13 1300, 14 1400, 15 1340 OHMS GROUP A (DTM ALGORITHM)#1) 15- 13+ 2.5 MA 200PW 50HZ#2) 2+ 4- 2.3MA 170PW 300HZ#3) 2+ 4- 2.3MA 170PW 300HZ#4) 2+ 4- 2.3MA 170PW 300HZ. THE SECOND IMPEDANCE CHECK SHOWED 0,1,4,5,6,7 RED. THE REP THEN REPROGRAMMED PATIENT TO USE ELECTRODES 2+ AND 3- FOR PROGRAMS 2,3 AND 4. THE IMPEDANCE CHECK IN LYING POSITION SHOWED 1720OHMS & 1750OHMS ( ELECTRODES 2 AND 3 RESPECTIVELY), WHICH INDICATES POSITIONAL IMPEDANCE CHANGES AS WELL. REVIEWED WITH REP THAT IF PATIENT IS GETTING COVERAGE THEN CONTINUE THE COURSE BUT IF RELIEF IS NOT AVAILABLE THEN CONSIDERATION FOR REVISION. THERE WAS NO KNOWN CAUSE OF IMPEDANCE CHANGE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTING THAT REPROGRAMMING THE PATIENT AROUND THE HIGH IMPEDANCES RESOLVED THE ¿SETTINGS NOT AVAILABLE¿ MESSAGE AND PROVIDED THE PATIENT EFFECTIVE THERAPY. IT WAS INDICATED THAT THE PROVIDED INFORMATION HAD BEEN CONFIRMED WITH THE PHYSICIAN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2079734 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97716 00643169781740

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male