BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 8621370 · Received May 17, 2019

    Report

    Report Number
    3004209178-2019-09848
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 4, 2018
    Report Date
    July 10, 2019
    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
    PA, 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. IT WAS REPORTED THAT THE PATIENT WAS IN A LOT OF PAIN. THE PATIENT SAID SHE NEEDS STIM TO REACH TO A FARTHER SPOT. THE PATIENT SAID IF SHE TURNS STIM UP, IT IS TOO HIGH, AND WHEN SHE TURNS STIM DOWN, IT IS TOO LOW. THE PATIENT SAID SHE WAS IN MORE PAIN BECAUSE SHE HAS BEEN WALKING MORE. THE PATIENT SAID SHE HAS CHRONIC PAIN ALL OF THE TIME AND SAID THAT IS WHY SHE HAS THE DEVICE. THE PATIENT SAID THE PAIN IS USUALLY ON THE LEFT SIDE, BUT SHE HAS PAIN ON HER RIGHT SIDE NOW. THE PATIENT MET WITH A REP FOR REPROGRAMMING IN (B)(6), AND MET WITH ANOTHER REP BEFORE THAT. THE PATIENT MENTIONED SHE HAD A KIDNEY STONE AND THE STIMULATION BOTHERED THAT AREA IF SHE INCREASED STIMULATION. THIS ISSUE OCCURRED IN (B)(6) 2019. NO FURTHER COMPLICATIONS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: DATE IS APPROXIMATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OUTCOME ATTRIBUTED TO ADVERSE EVENT: NONE. (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 A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT HAD NEW PAIN. THE PATIENT SAID THE PAIN WAS "LIKE FLANK PAIN, ON THE SIDE AT THE TOP OF THE HIP." THE PATIENT WAS UNSURE OF WHAT CAUSED THE NEW PAIN, BUT THOUGHT IT WAS A SIDE AFFECT OF THEIR SEIZURE MEDICATION. THE PATIENT STATED THEY STARTED EXPERIENCING SEIZURES AND THE INABILITY TO DRIVE AFTER THE INS WAS IMPLANTED. THE PATIENT SAID THEY WERE NOW ON MEDICATION FOR THE SEIZURES CALLED "KIPPERMINE." THE PATIENT SAID THAT WHEN THE STIMULATION WAS ON, THE STIMULATION AGGRAVATES THEIR NEW PAIN AND ALSO CAUSED UPPER BACK PAIN THAT COMPENSATES FOR THE LOWER BACK PAIN (THE REASON FOR THE DEVICE). THE PATIENT STATED THAT WHEN THE INS WAS OFF THEY STILL WERE IN PAIN IN THE NEW AREA, AND THE UPPER BACK PAIN GOES AWAY, BUT THE LOWER BACK PAIN BECOMES PRESENT AGAIN. THE PATIENT SAID THAT WHEN THE STIMULATION WAS ON "UP INTO THE RIB CAGE THERE IS BURNING AND WILL LOCK UP MY WHOLE LEFT SIDE UP TO NECK, THE MUSCLES NEXT SPINE AND UNDER ARM INTO ARMPIT. ITS LIKE ITS ON A NERVE AND IT HARD AS A ROCK." THE PATIENT SAID THEIR HEALTHCARE PROFESSIONAL (HCP) GAVE THEM MUSCLE RELAXERS FOR THIS ISSUE, BUT THE PATIENT HAD SINCE TURNED THE STIMULATION OFF TO MINIMIZE THIS EXPERIENCE. THE PATIENT SAID THEY WERE UNCLEAR WHAT CAUSES THIS. THE PATIENT MENTIONED THEY TAKE "OXY AND MEDICAL MARIJUANA" TO HELP WITH PAIN AND THEY GET ABOUT 2 HOURS OF RELIEF WHEN THEY TAKE THE MEDICATION. THE PATIENT ALSO REPORTED THAT ONLY GROUP A AND B WORKED FOR THEM AND GROUP C DID NOT WORK. THE PATIENT SAID THAT THESE PROGRAMS ONLY HELP THEIR REASON FOR THE DEVICE, BUT THEY CAUSED OTHER ISSUES. THE PATIENT STATED THEY JUST HAVE THE INS OFF AND MENTIONED THAT THE TRIAL WORKED SO WELL FOR THEM. THE PATIENT SAID THEY SPOKE WITH A MANUFACTURER REPRESENTATIVE (REP) ABOUT THE ISSUES AND THE REP SAID THEY COULD HELP REPROGRAM THE PATIENT. THE PATIENT STATED THAT AFTER THEY SAW THE REP, THE PULSE WIDTH AND RATE HAD CHANGED. THE PATIENT STATED THE RATE USE TO BE 800 AND NOW IT WAS 300, AND THE WIDTH USED TO BE 300 AND NOW IT WAS 800. THE PATIENT SAID THEY DID NOT KNOW IF THE REP CAUSED THIS, BUT NOW THEY COULDN'T GET THE DESIRED SETTINGS THEY WANTED. THE PATIENT SAID THEY COULD USUALLY BE ON GROUP A OR B AT 10V OR 11V WITH RATE AND WIDTH AROUND 40-120, OR THEY COULD BE ON GROUP A AND B AT 3V OR 4V WITH A RATE AND WIDTH OF 300-800. THE PATIENT MENTIONED THEY USED TO HAVE PROGRAMS A, B, C, D, E, AND F, BUT NOW THEY ONLY HAVE A AND B AND THEY "MESS AROUND WITH IT." THE PATIENT MENTIONED THEY HAD AN X-RAY AND IT SHOWED THAT ALL OF THEIR INTERNAL EQUIPMENT WAS IN THE CORRECT PLACE. THE PATIENT SAID THEIR HCP WAS SUGGESTING TO REPLACE THE INS BECAUSE "THERE IS BETTER TECHNOLOGY OUT." THE PATIENT WAS DIRECTED TO FOLLOW-UP WITH THEIR HCP AND A REP SAID THEY WOULD FOLLOW-UP WITH THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REPORTING THAT THE CAUSE OF THE SEIZURES WAS ¿REPORTEDLY MEDICATION RELATED (MEDICATION UNKNOWN, ASKED BUT WAS NOT GIVEN)¿. IT WAS ALSO INDICATED THAT THE SEIZURES WOULD STILL OCCUR WITH THE DEVICE OFF. NO DIAGNOSTIC TESTING WAS PROVIDED. IT WAS CLARIFIED THAT GROUP C WAS FUNCTIONAL, BUT WHEN THE AMPLITUDE WAS INCREASED IT WOULD BECOME UNCOMFORTABLE IN THE FLANK. REPROGRAMMING WAS PERFORMED TO RESOLVE THE ISSUE OF THE TRIAL WORKING BETTER FOR THE PATIENT AND THE PAIN/BURNING/THERAPY ISSUES. THE PATIENT¿S WEIGHT AT THE TIME OF THE EVENT WAS UNKNOWN. IT WAS INDICATED THAT THE PROVIDED INFORMATION HAD BEEN CONFIRMED WITH THE PHYSICIAN. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413560 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other