BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 10212782 · Received June 30, 2020

    Report

    Report Number
    3004209178-2020-11332
    Event Type
    Malfunction
    Date Received
    June 30, 2020
    Date of Event
    May 23, 2020
    Report Date
    July 2, 2020
    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
    GA, 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 REP. IT WAS REPORTED THAT THE PATIENT WAS REQUESTING REPROGRAMMING SINCE SHE HAD HER INS EXCHANGED/ REPLACED ON (B)(6) 2020 IN MICHIGAN. PATIENT DOES NOT HAVE AN HCP AND WANTED TO BE SEEN IN ATLANTA VA HOWEVER REP WAS NOT ALLOWED TO VA DUE TO COVID-19 RESTRICTIONS. PATIENT REQUESTED REP MEET AT HER HOME BUT REP EXPLAINED THIS WAS NOT LEGAL. ISSUE NOT RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT REGARDING THEIR IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT SINCE REPLACEMENT DUE TO NORMAL BATTERY DEPLETION, SHE HAS NOT HAD ANY THERAPEUTIC RELIEF IN THE LOWER BACK. THE NEW INS WAS PUT IN THE SAME SPOT, WHEN THE HCP WAS GOING TO PUT IT IN THE ABDOMEN AND NOW IT CONTINUES TO STICK OUT. THEY ALSO HAD PLANNED TO CHANGE OUT THE LEADS SO THAT SHE COULD GET COVERAGE FOR HER NEW PAIN IN HER LOWER BACK BUT THEY ENDED UP BRINGING THE WRONG SET OF LEADS TO THE SURGERY SO THEY WOULDN'T REACH. NOW SHE CAN'T GET ANYONE TO HELP HER WITH PROGRAMMING HER DEVICE SO THAT IT HELPS WITH HER LOW BACK PAIN. PATIENT STATED THAT THE NEW DEVICE IS SMALLER THAN THE OLDER INS. PATIENT HAD A FOLLOW UP APPOINTMENT WITH REP ON 6/3. REP TOLD PATIENT THEY CAN'T DO ANY FURTHER REPROGRAMMING UNTIL SHE IS REGISTERED IN THE SYSTEM. PATIENT HAS NOT GOTTEN ANY HELP SINCE. PATIENT ADDED THAT THE REPLACEMENT WAS DONE ON (B)(6) 2020 IN (B)(6) AND SHE LIVES IN (B)(6) NOW. THE NEW INS IS STICKING OUT OF HER HIP AND IT IS PAINFUL AND NOT HELPING THE LOWER BACK AND THORACIC AREA, SHE IS GETTING STIMULATION IN THE LEGS AND FEET. PATIENT NEEDS TO MEET WITH REP FOR ADJUSTMENT BUT DOES NOT HAVE HCP FOR THE STIMULATOR IN (B)(6). PATIENT WAS REDIRECTED TO SEE THE HCP. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT THE PLACEMENT OF THE DEVICE WAS INTENTIONAL. IT WAS DISCUSSED IN PRE-OPERATIVE WITH THE PATIENT WITH OTHER PHYSICIANS, NURSES AND THE REP PRESENT. THE REP REPORTED THAT THE INS STICKING OUT WAS A SUBJECTIVE ASSESSMENT OF THE INS. THE REP COULDN'T SPEAK TO THE ALLEGATION OF ¿ENDED UP BRING THE WRONG SET OF LEADS TO THE SURGERY SO THEY WOULD NOT REACH¿ AS THE CASE WAS BOARDED AND CONSENTED AS AN INS CHANGE DUE TO NORMAL DEPLETION ONLY; THERE WERE NO LEADS INVOLVED. NEW LEADS WERE NOT PLACED. THE REP REPORTED THAT THE LEADS WERE IN THE CORRECT PLACE AND THEY WERE THE CORRECT LENGTH. THE REP REPORTED THAT THE PATIENT¿S INS WAS PLACED FOR SCIATIC PAIN AND PER THE PATIENT, THEIR SCIATIC PAIN WAS BEING CONTROLLER. THE PATIENT WANTED THE INS TO CONTROL THE NEW PAIN. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677921 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR