BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 18943036 · Received March 20, 2024

    Report

    Report Number
    3004209178-2024-07442
    Event Type
    Malfunction
    Date Received
    March 20, 2024
    Report Date
    April 18, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000315474
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 977A260, SERIAL# (B)(6), IMPLANTED:(B)(6) 2023, PRODUCT TYPE LEAD SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977A260, SERIAL/LOT #: (B)(6), UBD: 21-OCT-2026, 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 977A260 SERIAL# (B)(6) IMPLANTED: (B)(6) 2023 PRODUCT TYPE LEAD 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 VIA MANUFACTURER REPRESENTATIVE WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). PATIENT CAME IN TODAY TO STATING THAT THEY CANNOT TURN STIMULATION INTENSITY UP WITHOUT GETTING AN ERROR MESSAGE. THE ERROR MESSAGE WAS UNABLE TO OBTAIN DESIRED INTENSITY. AFTER TALKING WITH PATIENT, PATIENT STATES APPROXIMATELY ONE MONTH TO A MONTH AND A HALF AGO THEY FELL DUE TO (UNRELATED) BLOOD PRESSURE MEDICATION ISSUES. PATIENT STATES THAT THEY HAVE NOT NOTICED A DIFFERENCE IN PAIN RELIEF. PATIENT STATED THE ONLY ISSUE IS OVER THE LAST WEEK OR SO. PATIENT HAS BEEN UNABLE TO TURNUP THE INTENSITY ON STIMULATOR. TODAY A REP PERFORMED AN IMPEDANCE CHECK AND FOUND THAT CONTACT 10 AND 11 HAD A POSSIBLE LOW IMPEDANCE/SHORT: CONTACT 10 - 29620, CONTACT 11- 30330. PATIENT WAS REPROGRAMMED AVOIDING CONTACTS 10 AND 11. PATIENT WAS ABLE TO STILL FEEL STIMULATION AFTER REPROGRAM AVOIDING THE CONTACTS THAT HAD A SHORT. THE ISSUE WAS RESOLVED. THE CAUSE IS BELIEVED TO BE DUE TO THE FALL. THE REP WILL REPORT ADDITIONAL INFORMATION THAT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT PROGRAMMED AROUND AN OOR. PT WAS TRYING TO TURN UP STIMULATION AND EXPERIENCED AN OOR. IMPEDANCE AND CONNECTIONS WERE TOTALLY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2048420 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97716 00763000315474

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female "SEE H11...."