BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 11711969 · Received April 22, 2021

    Report

    Report Number
    3004209178-2021-06492
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    April 1, 2021
    Report Date
    May 3, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    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. 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

    H2. CORRECTION: UPON FURTHER REVIEW, IT WAS REPORTED THAT THE INS WAS IMPLANTED IN NOVEMBER OF 2020. 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 WAS RECEIVED FROM THE REP. IT WAS REPORTED THAT THE PATIENT WAS REPROGRAMMED TO MAKE SURE THE PAIN AREA WAS BETTER COVERED. AFTER THE REPROGRAMMING THEY DID THE ORIENTATION AGAIN AND ALSO CHANGED THE ANGLE FOR XXLARGE WHEN LYING IN BED. AFTER 45 MINUTES, THE PROBLEM WAS RESOLVED AND THE ADAPTIVE STIMULATION WAS WORKED PERFECTLY WELL. THE ZAPPING WAS RESOLVED AND THE PATIENT WAS VERY HAPPY. IT WAS NOTED THAT THIS INFORMATION WAS CONFIRMED WITH THE PHYSICIAN/ACCOUNT.

    Additional Manufacturer Narrative · 1

    MFR SITE. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE [REP], FOREIGN) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT RECEIVED UNEXPECTED ZAPPING IN EARLY (B)(6) OF 2021 WHEN TRANSITIONING POSITIONS. THE REP WAS ATTEMPTING TO CORRECT ADAPTIVE STIMULATION FOR THE PATIENT WHO HAD PREVIOUSLY BEEN SUCCESSFUL WITH ADAPTIVE STIMULATION UNTIL NOTING A ZAPPING WHEN TRANSITIONING FROM LYING SIDE, WHICH WAS SET TO 5.5 MILLIAMPERES (MA), TO LYING BACK, WHICH WAS SET TO 1.5 MA. THE PATIENT HAD A 10 POUND WEIGHT LOSS AND THE BATTERY MOVING IN THE POCKET. THE REP DID REORIENTATION PRIOR TO CALLING THE MANUFACTURER'S TECHNICAL SERVICES. THE BATTERY WAS NOW STABLE AND IT WAS NOTED THAT THE PATIENT WAS WEARING A TIGHT UNDERGARMENT. THE REP ADJUSTED THE TRANSITION TIMES TO THE LOWEST VALUE, TRIED ADJUSTING THE ANGLES OF LYING BACK FROM EXTRA SMALL TO EXTRA LARGE THEN MEDIUM. A SECOND GROUP WAS CREATED WITH ALL THE VALUES COPIED BUT CHANGED LYING SIDE TO 3.0 MA AND LYING BACK AT 1.5 MA TO BE USED FOR SLEEPING, BUT THE INS RECOGNIZED LYING RIGHT WHILE LYING BACK. IT WAS REPORTED THAT THE PATIENT WAS TOO TIRED FOR ANYTHING ELSE, SO THEY WOULD RESET THE ORIENTATION AND VALUES AT A FURTHER TIME. A FOLLOW-UP APPOINTMENT WAS SET FOR (B)(6) 2021 AT 2 PM. IT WAS NOTED THAT THE ZAP WAS FROM ADAPTIVE STIMULATION NOT ADJUSTING QUICK ENOUGH IN TRANSITIONS TO OTHER POSITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607870 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715

    Patients

    Seq Age Sex Outcome Treatment
    1