BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 13892110 · Received March 24, 2022

    Report

    Report Number
    3004209178-2022-03719
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    August 7, 2018
    Report Date
    March 24, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97745, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97755, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. 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

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THEY HAVE HAD ISSUES WITH CHARGING THEIR IMPLANT SINCE LAST JULY. PT SAID THAT THEY LOST 125 LBS AND ARE SO MUCH SKINNER THAN THEY WERE WHEN THEY GOT THE IMPLANT. PT SAID THAT THEIR IMPLANT HAS MOVED ABOUT 2 INCHES. PT SAID THAT THEY WILL PUT THE RECHARGER ON TO CHARGE THEIR IMPLANT AND JUST SIT THERE AND THE CHARGING SESSION WILL STOP. PT SAID THEY WERE GETTING EPIDURAL INJECTIONS WITH THEIR DOCTOR FOR THEIR PAIN YESTERDAY AND THEY TOLD THEM ABOUT THE ISSUE AND THE DOCTOR TOLD THEM TO CALL MEDTRONIC (SEE (B)(4) FOR REPORT OF PAIN AND EPIDURAL INJECTIONS). PT SAID THEY CALLED MEDTRONIC REP (B)(4) (LAST NAME ASKED, UNKNOWN) YESTERDAY REGARDING THE ISSUE AND MET WITH MEDTRONIC REP, (B)(4) (LAST NAME UNKNOWN) REGARDING THE ISSUE TODAY. PT SAID THAT MEDTRONIC REP (B)(4) PULLED UP LOGS AND COULD SEE HOW LONG THEIR IMPLANT BATTERY WAS TAKING TO CHARGE AND WHEN THE CHARGE WOULD STOP AND THEY SAID THIS SHOULDN'T BE HAPPENING. PT SAID THE MEDTRONIC REP TOLD THE PT TO CALL PS AND REQUEST A REPLACEMENT CONTROLLER AND RECHARGER BE SENT TO SEE IF THEY CAN RESOLVE THE ISSUE WITHOUT HAVING TO GO INTO SURGERY AGAIN TO MOVE THE IMPLANT BATTERY. PT ALSO MENTIONED ON THE CALL THAT THEY FELT LIKE THEY WERE BEING "SHOCKED" WHEN THEY WERE CHARGING THEIR IMPLANT WHILE LAYING DOWN; PT MENTIONED IT FEELING REALLY "TINGLY". PT SAID THE LIE DOWN TO CHARGE BECAUSE THEY GET THE BEST CONNECTION FOR CHARGING THAT WAY. PT ALSO MENTIONED THE REPS ASKING IF PS COULD DO A FACTORY RESET.  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PT REPORTED THAT SINCE IMPLANT THE THERAPY HAS WORKED AND DAMPENED THE PAIN BUT THEY STILL HAVE BAD PAIN; PT SAID THE IMPLANT DOESN'T GIVE THEM FULL PAIN RELIEF. PT MENTIONED GETTING EPIDURAL SHOTS FOR THE PAIN YESTERDAY WITH THEIR DOCTOR. PSS DOCUMENTING PAST EVENT THAT WAS REPORTED BY THE PT ON THE CALL. SEE CASE # (B)(4) FOR THE REPORT OF IMPLANT CHARGING ISSUES AND THAT IMPLANT HAD MOVED THAT WAS MENTIONED ON THE CALL. PATIENT IS HAVING ISSUES WITH CHARGING THEIR IMPLANT AND THE IMPLANT BATTERY HAS MOVED DUE TO WEIGHT LOSS. BEFORE DECIDING ON SURGERY TO MOVE THE IMPLANT BATTERY, MEDTRONIC REP REQUESTED NEW CONTROLLER AND RECHARGER BE SENT.  MEDTRONIC REPS DID TROUBLESHOOTING WITH PATIENT ALREADY.  - NO PATIENT INJURY REPORTED PSS REDIRECTED PT TO REP TO HAVE THEM CONTACT TECH SVS FOR REVIEWING THIS. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE CONTROLLER AND RECHARGER. SEE CASE # (B)(4) FOR THE REPORT OF RECHARGER REPLACEMENT AND CONTROLLER REPLACEMENT THAT WERE MENTIONED ON THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986817 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male