BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 7872886 · Received September 13, 2018

    Report

    Report Number
    3004209178-2018-20558
    Event Type
    Malfunction
    Date Received
    September 13, 2018
    Date of Event
    August 28, 2018
    Report Date
    October 18, 2018
    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
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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 RECEIVED FROM THE CONSUMER REPORTED THAT A FALL WAS THE CAUSE OF THE STIMULATION IN THEIR SIDE. THE PATIENT HAD A PROGRAM C ADDED TO THE EXISTING PROGRAMS A AND B AND THE STIMULATION ISSUE WAS RESOLVED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 977A260 LOT# SERIAL# (B)(4) IMPLANTED: (B)(4) 2018 EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 977A260 LOT# SERIAL# (B)(4) IMPLANTED: (B)(4) 2018 EXPLANTED: PRODUCT TYPE LEAD 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

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER REPORTED THAT THE CAUSE OF THE STIMULATION IN THE SIDE WAS THAT THE PATIENT FELL FIVE WEEKS AGO. A FLUORO OF THE LEADS ON (B)(4) SHOWED MINIMAL LEAD MIGRATION. REPROGRAMMING WAS DONE ON (B)(4) AND HAD RESOLVED THE ISSUE SO FAR.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT STATED THAT THEY HAD TO CHARGE THE DEVICE UP QUITE A BIT AND THE PATIENT WAS FEELING STIMULATION IN THEIR SIDE AND NOT IN THEIR BACK SINCE (B)(6) 2018 (THE PATIENT STATED TWO WEEKS AGO). THE PATIENT REPORTED THAT THEY HAD A FALL IN 2018. A COUPLE OF WEEKS AGO. THE PATIENT STATED THAT THEY HAVE TRIED TO ADJUST THE THERAPY ON THEIR OWN, BUT CANNOT GET STIMULATION IN THEIR BACK. THE PATIENT WAS REDIRECTED TO FOLLOW-UP WITH THE HEALTHCARE PROVIDER (HCP) TO HAVE THEIR INS AND LEADS CHECKED. A MESSAGE WAS SENT TO THE FIELD. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714436 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR