BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 18584796 · Received January 25, 2024

    Report

    Report Number
    3004209178-2024-02266
    Event Type
    Malfunction
    Date Received
    January 25, 2024
    Date of Event
    June 11, 2023
    Report Date
    January 25, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID M995402A001 SERIAL# (B)(6) PRODUCT TYPE SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: M995402A001, SERIAL/LOT #: (B)(6), H3: ANALYSIS OF THE 97745BP BATTERY PACK (S/N (B)(6)) REVEALED THAT THE COMPLAINT WAS UNABLE TO BE VERIFIED. THIS REGULATORY REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AS PART OF A REMEDIATION PLAN 411 ACTION. 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 PATIENT (PT) REGARDING AN EXTERNAL DEVICE. IT WAS REPORTED THAT STARTING YESTERDAY THE PT WAS HAVING A PROBLEM WITH THE CONTROLLER/PATIENT TELEMETRY MODULE (PTM) GOING OUT, PT SAID IT WAS LIKE IT GOT TURNED OFF. THE PTS PTM SCREEN WOULD GO BLANK WHEN NOTHING WAS PLUGGED INTO IT. THE ONLY WAY TO GET THE PTM TO TURN ON WAS TO PLUG THE PTM INTO THE AC POWER SUPPLY. PT NOTED IF THEY WERE TO BUMP THE PTM THEN THE SCREEN WOULD GO BLANK. PT HAD PUT TWO AA BATTERIES INTO THE PTM, AND IT TURNED ON. PLUGGED THE PTM INTO THE AC POWER SUPPLY, PT VERIFIED THE PTM TURNED ON. PT PUT THE BATTERY BACK INTO THE PTM AND VERIFIED THE PTM WAS CHARGING. THE PT UNLOCKED THE PTM AND THE BATTERY WAS AT 100% AND THE IMPLANTED NEUROSTIMULATOR (INS) WAS AT 80%. PT UNPLUGGED PTM FROM THE AC POWER SUPPLY AND THE PTM STAYED TURNED ON. PT BUMPED THE PTM WHILE IT WAS TURNED ON AND WHEN NOTHING WAS PLUGGED INTO THE PTM, AND IT STAYED ON. NOTHING WAS LOOSE IN THE PTM WHEN SHOOK. THE TROUBLESHOOTING STEPS THAT WERE TAKEN ON THE CALL RESOLVED THE ISSUE. PT CALLED BACK AND WAS STILL HAVING ISSUES WITH THEIR PTM GOING OUT. PT NOTED NOTHING WAS CONNECTED TO THE PTM. DURING THE CALL AND PT DENIED VISIBLE DAMAGES IN THE BATTERY, BATTERY COMPARTMENT, AND PTM CHARGING PORT. A REPLACEMENT CONTROLLER WAS SENT OUT. ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT (PT). IT WAS REPORTED THAT THEY RECEIVED THE REPLACEMENT CONTROLLER AND ARE STILL HAVING ISSUES WITH THEIR CONTROLLER. PT STATED THE CONTROLLER WILL ONLY POWER ON IF AA BATTERIES ARE INSERTED. A REPLACEMENT BATTERY PACK WAS SENT OUT. NO SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356760 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male "SEE H10...."