BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 15789710 · Received November 14, 2022

    Report

    Report Number
    3004209178-2022-14979
    Event Type
    Injury
    Date Received
    November 14, 2022
    Date of Event
    July 19, 2022
    Report Date
    December 8, 2022
    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
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977A260, SERIAL/LOT #: (B)(4), UBD: 23-APR-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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN INDICATIONS. PT SAW MANAGING HCP ON JULY 19 FOR ISSUES WITH THERAPY AND HIGH IMPEDANCES THAT WERE SEEN DURING THAT VISIT. THE HCP USED THE "GREEN" VALUES ON THEIR IMPED CHECK TO REPROGRAM PT BUT THIS DIDN'T RESULT IN ANY THERAPY BENEFIT FOR THE PT. CALLER SAW PT TODAY AND ALL OF LEFT LEAD IS BETWEEN 2700 AND 4000 AND 8, 10 AND 13 ON RIGHT SIDE ARE AROUND 2700 WITH OTHER ELECTRODES >40,000. PT HAD BEEN SEEING "SETTINGS NOT AVAIL" ON THEIR REMOTE SINCE JULY 19 DUE TO ELEVATED/HIGH IMPEDANCES. TSS REVIEWED LIMITED OUTPUT RELATED TO ELEVATED AND HIGH IMPED. PT PREVIOUSLY USING DTM SETTINGS BUT THAT PROTOCOL ISN'T BEING FOLLOWED STRICTLY ANYMORE. PT SEEING MORE SETTINGS NOT AVAIL MESSAGES ON GROUP A COMPARED TO GROUPS B <(>&<)> C. TSS REVIEWED THAT IF THEY COULD LOWER PW OR RATE AND TRY TO USE ELECTRODE PAIRS WITH LOWER IMPED (IF AVAIL) THEY MAY BE ABLE TO GET MORE OUTPUT FROM INS. ALSO REVIEWED POTENTIAL NEED FOR LEAD REVISION IF THERAPY CAN'T BE RECAPTURED. REP CLARIFIED THE THERAPY ISSUES WERE DUE TO NOT ALLOWING PATIENT TO INCREASE THERAPY ON REMOTE DUE TO ENERGY USED. THE HIGH IMPEDANCES MADE PATIENT UNABLE TO INCREASE THERAPY. REP MOVED ONE OF HIS DTM PROGRAMS TO TONIC ON THE DATE THE PHONE CALL TO PATIENT SERVICES. ISSUE HAS BEEN RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE PATIENT HAD A REVISION FOR THE HIGH IMPEDANCES. TOOK THIS LEAD OUT AND REPLACED WITH ANOTHER NEW LEAD. THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    PT CALLED ABOUT CHARGING ISSUE IN RTG0375842 AND DURING THE CALL REPORTED INFORMATION RELATED TO THIS CASE. PT SAID THEY HAD TO REPLACE THE LEAD LAST FRIDAY BECAUSE THE LEAD WASN'T WORKING. PT SAID THE REP TRIED AND TRIED RELATED TO THE ISSUE IN THIS CASE, BUT ENDED UP NEEDING TO HAVE THE LEAD REPLACED. PT SAID WHEN DOCTOR WAS IN THERE THEY CHECKED THE CONNECTION BETWEEN THE LEAD AND INS, BUT THAT WASN'T THE ISSUE. PSS DOCUMENTED INFORMATION GIVEN DURING THE CALL. NO NEW REPORTABLE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830272 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention "SEE H10."