BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 13562152 · Received February 18, 2022

    Report

    Report Number
    3004209178-2022-02260
    Event Type
    Malfunction
    Date Received
    February 18, 2022
    Date of Event
    January 14, 2022
    Report Date
    March 1, 2022
    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
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    G3: UPDATED TO 2022-(B)(6), WAS 2022-(B)(6). PER THE NEW INFORMATION, PREVIOUSLY REPORTED FDD CODE A0722 IS NO LONGER APPLICABLE TO THE EVENT. 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 MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT LEAD IMPEDANCE ISSUES WERE FOUND ON ELECTRODES 8 AND 14.

    Description of Event or Problem · 0

    IMPEDANCE VALUES OUT OF RANGE WERE IDENTIFIED ON (B)(6)2022 WHILE REVIEWING DEVICE INTERROGATION REPORTS UPLOADED TO NPU. IMPEDANCE VALUES 40000 FOR ELECTRODE 8 ALL PAIRS AND ELECTRODE 14 ALL PAIRS FOR THE FOLLOWING REPORTS: (B)(6)2022 09:45:34 (B)(6)-2022 09:22:16 (B)(6)-2022 09:27:30 IMPEDANCE VALUES 40000 FOR ELECTRODE 8 ALL PAIRS, AND FOR ALL ELECTRODE 14 VALUES SPECIFIED BELOW: REPORT (B)(6)-2022 AT 09:23:35 0 <(>&<)> 14 34170 1 <(>&<)> 14 34090 2 <(>&<)> 14 35570 3 <(>&<)> 14 37030 4 <(>&<)> 14 37230 5 <(>&<)> 14 37250 6 <(>&<)> 14 38040 7 <(>&<)> 14 39480 9 <(>&<)> 14 39760 10 <(>&<)> 14 40000 11 <(>&<)> 14 40000 12 <(>&<)> 14 40000 13 <(>&<)> 14 40000 14 <(>&<)> 15 40000 ACTIONS TAKEN AND OUTCOME WERE UNKNOWN AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16583 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male