BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 20081772 · Received August 27, 2024

    Report

    Report Number
    3004209178-2024-17473
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    June 12, 2024
    Report Date
    August 27, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000315467
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 3998 LOT# V163064 SERIAL# IMPLANTED: (B)(6) 2011 EXPLANTED: PRODUCT TYPE LEAD SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3998, SERIAL/LOT #: (B)(6), UBD: 08-OCT-2012, UDI#: (B)(4). MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THEY ARE GETTING SETTINGS NOT AVAILABLE, CANNOT PROVIDE YOUR DESIRE SETTING MESSAGE ON THE CONTROLLER SINCE ABOUT A WEEK AGO. PATIENT SERVICES SPECIALIST REVIEWED MEANING OF MESSAGE AND RECOMMEND PATIENT CONSULT WITH HEALTHCARE PROVIDER OFC FOR NEXT STEPS. AGENT CONFIRMED PATIENT TRIED DIFFERENT GROUPS AND PROGRAMS AND THEY ARE GETTING THE SAME MESSAGE. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. IT WAS REPORTED THAT THE CAUSE OF THE ISSUE WAS ONE OF THE LEADS WAS DISCONNECTED. PATIENT REPORTED A "TECH" TURNED THAT LEAD OFF. PATIENT NOTED THE ISSUE IS RESOLVED, AND THEIR SPINE STIM WORKS AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191294 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female