BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 17334611 · Received July 17, 2023

    Report

    Report Number
    3004209178-2023-12758
    Event Type
    Injury
    Date Received
    July 17, 2023
    Date of Event
    June 2, 2023
    Report Date
    July 17, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000315467
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 977A260 , SERIAL# (B)(6), IMPLANTED: (B)(6) 2021, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL#: (B)(6) , IMPLANTED: (B)(6) 2021. 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: 24-JUN-2025, UDI#: (B)(4); PRODUCT ID: 977A260, SERIAL/LOT #: (B)(6), UBD: 24-JUN-2025, UDI#: (B)(4). 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

    2 INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES: 2 - 23790, 7- 17880, 10- 23640, 11- 23790, 12- 23790, 15- 23740. ALL ELECTRODES ABOVE ORANGE ON IMPEDANCE CHECK. MET WITH PATIENT AS SHE WAS SEEING ¿UNABLE TO PROVIDE DESIRED INTENSITY¿ ON REMOTE. THE PATIENT ALSO HAD A LOSS OF STIMULATION AND A RETURN OF PAIN. ON CONNECTING TO BATTERY, IMPEDANCE VALUES ABOVE WERE OBSERVED. RED XS PRESENT ON LEAD CONNECTION CHECK AT ELECTRODE 11 AND 12. THE REP WAS NOT PRESENT ON DAY OF SURGERY BUT THERE IS NO DOCUMENTATION TO SUGGEST THESE WERE PRESENT ON DAY OF SURGERY. REPROGRAMMED NOT USING ANY OF THE ELECTRODE ABOVE. THE ISSUE WAS RESOLVED. ON (B)(6) 2023 THE REP MET WITH THE PATIENT (PT) ON (B)(6) 2023 AND AN IMPEDANCE CHECK WAS PERFORMED. NO RED X'S PRESENT ON ANY ELECTRODES. HCP WAS NOTIFIED OF IMPEDANCE ISSUES. HCP SPOKE WITH PT ABOUT POSSIBLE LEAD REVISION IN AUGUST. REP REPROGRAMMED PT DEVICE TO LD SETTING TO PROGRAM AROUND IMPEDANCES. ON (B)(6) 2023 THE REP REPORTED THE PATIENT WOULD BE IN TOUCH WITH THEIR HCP TO GET REVISION SCHEDULED, BUT MAY NOT YET BE SCHEDULED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1663712 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention "SEE H10...."