BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 18711937 · Received February 15, 2024

    Report

    Report Number
    3004209178-2024-04827
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    January 25, 2022
    Report Date
    February 15, 2024
    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
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLA NTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT GROUP A IS THE ONLY ONE EFFECTIVE FOR THE PATIENT. GROUP B AND C DID NOT WORK. SINCE IMPLANT WAS DONE THE THERAPY HAS BEEN MORE EFFECTIVE FOR HER LEG AND NOT SO MUCH WITH HER LOWER BACK PAIN. THE CAUSE WAS UNKNOWN. HCP REQUESTED A REP TO MEET WITH PATIENT AFTER HE HAD SEEN HER IN HIS OFFICE AND THAT SHE WAS WILLING TO WAIT. REP MET WITH THE PATIENT WITHIN 45 MINUTES OF HCP'S REQUEST. UPON INTERROGATION OF PATIENT'S IPG. IT WAS NOTED THAT ELECTRODE NUMBER 12 WAS GREATER THAN 40,000 OHMS. GROUPS B & C HAD INCLUDED ELECTRODE #12. EXTENSIVE EDUCATION DONE WITH PT WITH RETURN DEMONSTRATION DONE OF ACCESSING DIFFERENT GROUPS AND DIFFERENT PROGRAMS. DENUMBER 12 INC., SO REPROGRAMMED GROUPS AB AND C. UNKNOWN LEAD SN WHICH HAS ELECTRODE 12 AS OPEN CIRCUIT. AS IT IS NOT DOCUMENTED WHICH SERIAL NUMBER IS 0-7 (LEFT) VERSUS 8-15 (RIGHT).  REP SPOKE WITH THE PATIENT THIS EVENING AND SHE STATED THAT THE NEWLY PROGRAM GROUP C, WHICH SHE HAS HAD ACTIVATED SINCE OUR MEETING THIS EARLIER WEEK, IS WORKING BETTER FOR HER THAN THE PREVIOUS PROGRAMMING. THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2090863 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female