BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 7560121 · Received June 1, 2018

    Report

    Report Number
    3004209178-2018-12326
    Event Type
    Malfunction
    Date Received
    June 1, 2018
    Date of Event
    May 16, 2018
    Report Date
    January 31, 2023
    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
    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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). PT MENTIONED THEY COULD NOT GAIN THERAPY FROM EITHER OF THEIR IMPLANTS. PT MENTIONED IF THEY TRIED TO INCREASE STIMULATION, THEY WOULD GET ZAPPED IN THE RIBCAGE. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. PATIENT SERVICES (PSS) OFFERED TO PROVIDE NATIONAL ANSWERING SERVICE NUMBER, PATIENT DECLINED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 97715, SERIAL# (B)(4), IMPLANTED: (B)(6) 2018, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 PRIOR TO GETTING THEIR INS REPROGRAMMED BY THE MANUFACTURING REPRESENTATIVE (REP), THEY HAD A ¿SHOCK¿ IN THEIR RIBS INSTEAD OF THEIR LEGS. THE PATIENT CLARIFIED THAT THE ¿SHOCK¿ MEANT THAT THEY WERE FEELING STIMULATION IN THE WRONG LOCATION. THEY INDICATED THAT DECREASING THE STIMULATION FIXED THE STIMULATION. THE PATIENT STATED THAT THEIR RIGHT SIDE IS FINE, BUT THEIR LEFT SIDE IS WORSE. THEY MENTIONED HAVING A ¿SETTINGS NOT AVAILABLE¿ MESSAGE AGAIN. THE PATIENT ADDED THAT THEY NEED THE STIMULATION HIGHER BECAUSE THEY ARE STILL IN PAIN BUT CAN'T INCREASE IT FURTHER DUE THE MESSAGE. THEY NOTED THAT AFTER REPROGRAMMING WAS DONE WITH THE REP, THEY CAN'T GO ANY HIGHER THAN 5.7. THE PATIENT ADDED THAT ONE SIDE IS AT 5.7, THEN LATER INDICATED 5.8, AND THE OTHER SIDE IS AT 2.9. THEY MENTIONED THAT THEY USED TO BE ABLE TO INCREASE TO 6.0. PATIENT SERVICES WALKED THE PATIENT THROUGH SWITCHING TO GROUP B AT THE TIME OF THE REPORT, BUT THE STIMULATION WAS IN THE PATIENT¿S THIGHS, AND THEY NEED IT IN THEIR FEET TO ASSIST WITH THEIR NEUROPATHY. THE PATIENT WAS RE-DIRECTED TO THEIR HEALTHCARE PROVIDER. THE PATIENT STATED THAT THEY WILL REACH OUT TO THEIR MANUFACTURING REPRESENTATIVE. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PERIPHERAL NEUROPATHY AND SPINAL PAIN. IT WAS REPORTED THAT THE REP SAW A ¿SETTINGS NOT AVAILABLE¿ SCREEN ON THE CONTROLLER. THE PATIENT WAS GETTING THE MESSAGE AT 5.7 MA. IMPEDANCES WERE 880-970 OHMS. THE PATIENT WAS PROGRAMMED ON 4+ AND 5-, 90 PW, 500 HZ. IT WAS NOTED THAT CHANGING PW AND HZ CHANGED HOW THE PATIENT FEELS STIM. ADDING AN ELECTRODE ALSO CHANGED STIM TO AN UNDESIRED EFFECT. THE REP WAS GOING TO PLAY WITH REPROGRAMMING THE DEVICE, BUT THEY HAD DONE SOME EXHAUSTIVE WORK, WITHOUT GETTING THE STIM THAT THE PATIENT WANTED. THE REP ALSO REPORTED THE PATIENT NEEDED TO RECHARGE EVERY 36 HOURS. THE REP WAS GOING TO TRY CYCLING TO SEE IF THE PATIENT CAN TOLERATE IT TO ALLOW FOR A LONGER RECHARGE INTERVAL. NO SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403073 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female "SEE H10...."