BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 11649346 · Received April 12, 2021

    Report

    Report Number
    3004209178-2021-05849
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    March 26, 2021
    Report Date
    March 17, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT REPORTING THAT THEIR INS WAS CONTINUOUSLY MOVING SINCE IMPLANTED. PT DID TELL DR. EYKE ABOUT THE SITUATION. PT NOTED THAT THE INS WAS MOVING TOWARDS THE SIDE FROM CENTER TO SIDE. THE IMPLANT HAD MOVED QUITE A BIT FOR THE INS USE TO SIT ON TARGET AND THE PT KNEW WHERE THE INS WAS BUT NOW IT FELT LIKE THE INS HAD MOVED AGAIN FOR PT THOUGHT THE INS HAD DRIFTED. PT NOTED THE INS CAME OUT OF POCKET AND WAS MOVING RIGHT AWAY. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HER BATTERY MOVED. THE PATIENT STATED THAT NOW THE RECHARGING IS VERY DIFFICULT. THE PATIENT STATES THAT THE IMPLANTABLE NEUROSTIMULATOR HAS BEEN MIGRATING OVER THE PAST COUPLE OF WEEKS, CONFIRMED TO HAVE STARTED IN (B)(6) 2021. THE PATIENT STATES THAT IT ALMOST FEELS AS THOUGH THE IMPLANTABLE NEUROSTIMULATOR HAS TURNED. SHE TRIED TO ATTEMPT A CHARGE SESSION AND WAS HAVING A VERY HARD TIME GETTING CONNECTION AS THE IMPLANTABLE NEUROSTIMULATOR HAD MOVED. THE IMPLANTABLE NEUROSTIMULATOR FEELS BUMPY AND IT USED TO BE SMOOTH. THE PATIENT WAS ABLE TO SEE RECHARGING EXCELLENT FOR A FEW MINUTES, AND SHE WAS HOPING THAT SHE CAN GET THE IMPLANTABLE NEUROSTIMULATOR CHARGED AS HER IMPLANTABLE NEUROSTIMULATOR IS DEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544817 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female