BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 17117588 · Received June 13, 2023

    Report

    Report Number
    3004209178-2023-10684
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    December 24, 2022
    Report Date
    June 13, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Removal / Correction Number
    Z-1535-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 97755 LOT# SERIAL# (B)(6) IMPLANTED: EXPLANTED: PRODUCT TYPE RECHARGER PRODUCT ID 97745 LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 97755, SERIAL/LOT #: (B)(6), UBD: , UDI#: H3: ANALYSIS OF THE 97755 RECHARGER (RTM) (S/N (B)(6)) REVEALED A FAILURE, BATTERY LOW, REPLACE BATTERIES SOON MESSAGE APPEARS WHEN TRYING TO CHARGE. NO ANOMALIES WERE VISUALLY OBSERVED. THIS REGULATORY REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AS PART OF A CAPA 620188 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. 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 TO AN IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANTED FOR NON- MALIGNANT PAIN INDICATIONS. IT WAS REPORTED THAT ABOUT A WEEK BEFORE (B)(6) 2022, THEY BEGAN HAVING ISSUES WHILE CHARGING THEIR INS. PT STATED THAT SYSTEM PROBLEM MESSAGES BEGAN TO DISPLAY. PT DID NOT HAVE FURTHER DETAILS OF THE SYSTEM PROBLEM MESSAGES BUT LATER IN THE CONVERSATION STATED THAT SOFTWARE PROBLEMS CONTINUED TO OCCUR. PT STATED THAT THE FOLLOWING SOFTWARE PROBLEM DISPLAYED: 1-INTELLIS, 2 - 3.6, 3 - 45, 4 - QTE-ARM. PT STATED THEY RESET THE CONTROLLER BUT THE ISSUES CONTINUED TO DISPLAY. PT STATED THEY SPOKE WITH THEIR MANUFACTURER REPRESENTATIVE (REP) AND WAS INSTRUCTED TO CONTACT THE MANUFACTURER'S PATIENT SERVICES FOR ASSISTANCE. PT CONFIRMED THAT THE RECHARGER STARTED BECOMING WARMER THAN USUAL WHILE CHARGING. THE ISSUE WAS NOT RESOLVED. PT ALSO COMMENTED THAT THEY CHARGE THEIR INS ABOUT EVERY 2.5 DAYS AND THEY ARE MEETING WITH REP TOMORROW FOR ROUTINE PROGRAMMING. NO SYMPTOMS WERE REPORTED. A REPLACEMENT RECHARGER WAS SENT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171492 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female