BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 11586084 · Received March 29, 2021

    Report

    Report Number
    3004209178-2021-05099
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    February 2, 2021
    Report Date
    March 30, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: 977C265, SERIAL# (B)(6), IMPLANTED: (B)(6) 2021, AND PRODUCT TYPE: LEAD. 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

    ADDITIONAL INFORMATION RECEIVED FROM THE REP INDICATED THAT THE CAUSE OF THE HIGH IMPEDANCES WAS UNKNOWN. THEY STATED THAT THE PATIENT IS TO REPORT BACK IF THEY'D LIKE REPROGRAMMING FOR SATISFACTORY PAIN RELIEF. IT IS UNKNOWN IF THE ISSUE RESOLVED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 977C265 LOT# SERIAL# (B)(4) IMPLANTED: 2021 (B)(6) EXPLANTED: PRODUCT TYPE LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTI MULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAD IMPEDANCE ISSUE SINCE IMPLANT OF THE PADDLE LEAD. THE REP REPORTS PHYSICIAN WANTED THE IMPEDANCE TO STABILIZED AND REPROGRAMMED AFTER THE PADDLE LEAD HAD STABILIZED. THE REP REPORTS USING ELECTRODE 0/6 PATIENT FEELS ON HIS RIGHT THIGH. AND ELECTRODE 8-15, WHEN PATIENT INCREASED STIMULATION, OUT OF REGULATION (OOR) OCCURS. THE REP DIDN'T KNOW WHEN THE OOR MESSAGE STARTED APPEARING. THE REP REPORTS SHE HAS TRIED REPROGRAMMING ALL CONTACTS AND IS GETTING OOR MESSAGES. THE  INS IS CHARGED UP TO 60%. CALLER REPORTS PATIENT'S 0-7- COVERS THE RIGHT SIDE AND 8-15: COVERS THE LEFT. ELECTRODE IMPEDANCE TESTED: REFERENCE 89: 810 OHMS10: 930 OHMS11: 900 OHMS12: 880 OHMS13: 930 OHMS14: 960 OHMS15: 900 OHMS REFERENCE 98: 810 OHMS10: 810 OHMS11: 870 OHMS12: 870 OHMS13: 920 OHMS14: 940 OHMS15: 880 OHMS REFERENCE 108: 930 OHMS9: 810 OHMS11: 830 OHMS12: 890 OHMS13: 960 OHMS14: 1000 OHMS15: 960 OHMS REFERENCE 118: 900 OHMS9: 870 OHMS10: 870 OHMS12: 740 OHMS13: 880 OHMS14: 950 OHMS15: 890 OHMS REFERENCE 128: 880 OHMS9: 870 OHMS10: 890 OHMS11: 740 OHMS13: 700 OHMS14: 760 OHMS15: 750 OHMS REFERENCE 138: 930 OHMS9: 920 OHMS10: 960 OHMS11: 880 OHMS12: 700 OHMS14: 730 OHMS15: 770 OHMS REFERENCE 148: 960 OHMS9: 940 OHMS10: 1000 OHMS11:950 OHMS12: 760 OHMS13: 730 OHMS15: 700 OHMS REFERENCE 158: 900 OHMS9: 880 OHMS10: 960 OHMS11: 890 OHMS12: 750 OHMS13: 770 OHMS14: 700 OHMS REFERENCE 01: 12860 OHMS2: 2990 OHMS3: 27150 OHMS4: 34940 OHMS5: 33730 OHMS6: 660 OHMS7: 34990 OHMS REFERENCE 10: 12860 OHMS2: 40000 OHMS3: 39770 OHMS4: 40K OHMS5: 40K OHMS6: 10430 OHMS7: 40K OHMS REFERENCE 20: 29990 OHMS1: 40K OHMS3: 40K OHMS4: 40K OHMS5: 40K OHMS6: 29920 OHMS7: 40K OHMS REFERENCE 30: 27510 OHMS1: 39770 OHMS2: 40K OHMS4: 40K OHMS5: 40K OHMS6: 22600 OHMS7: 40K OHMS REFERENCE 40: 39940 OHMS1: 40K OHMS2: 40K OHMS3: 40K OHMS5: 40K OHMS6: 40K OHMS7: 40K OHMS REFERENCE 50: 33730 OHMS1: 40K OHMS2: 40K OHMS3: 40K OHMS4: 40K OHMS6: 40K OHMS7: 40K OHMS REFERENCE 60: 660 OHMS1: 4530 OHMS2: 29920 OHMS3: 22600 OHMS4: 40K OHMS5: 40K OHMS7: 34950 OHMS REFERENCE 70: 34990 OHMS1: 40K OHMS2: 40K OHMS3: 40K OHMS4: 40K OHMS5: 40K OHMS6: 34950 OHMS. THE REP REPORTS REPROGRAMMING USING ELECTRODE 0/6: 300PW/50HZ. PATIENT FEELS ON HIS LEFT KNEE USING ELECTRODE: 0/2: OOR OCCURRED AT 2.5MA. USING ELECTRODE: 6/1: OOR OCCURRED AT 2.8MA. THE REP REPORTS PATIENT WANTS BILATERAL FEET COVERAGE. USING ELECTRODE: 10/14: 300PW/50HZ. PATIENT FEELS COMFORTABLE STIMULATION, COVERS BOTH FEET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481198 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR