BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 7961693 · Received October 12, 2018

    Report

    Report Number
    3007566237-2018-03028
    Event Type
    Injury
    Date Received
    October 12, 2018
    Date of Event
    October 10, 2018
    Report Date
    November 29, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D11: PRODUCT ID 3887-45 LOT# (B)(4) SERIAL# IMPLANTED: (B)(6) 2003 PRODUCT TYPE LEAD. PRODUCT ID 3887-45 LOT# (B)(4)SERIAL# IMPLANTED: (B)(6) 2003 PRODUCT TYPE LEAD. PRODUCT ID 3986ILC LOT# (B)(4) SERIAL# IMPLANTED: (B)(6) 2002 PRODUCT TYPE LEAD. PRODUCT ID 3986ILC LOT# (B)(4) SERIAL# IMPLANTED: (B)(6) 2002 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 WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE ON 2018-NOV-15 REPORTING THAT ON THE DAY OF THE EVENT THE HEALTH CARE PROVIDER (HCP) AND MANUFACTURER REPRESENTATIVE BOTH TRIED TO PROGRAM MANY DIFFERENT ELECTRODE CONFIGURATIONS IN ATTEMPTS TO BRING STIMULATION TO PERCEPTION WITHOUT SUCCESS. THE HEALTH CARE PROVIDER (HCP) ORDERED IMAGING TO THE LEADS. AFTER THE X-RAY IMAGES WERE PROVIDED, IT WAS ABLE TO BE DETERMINED THAT THE PATIENT HAD A TOTAL OF 3 LEADS IMPLANTS. ONE THE LEADS WAS NOT FUNCTIONING AND IT WAS BELIEVED BY THE REPRESENTATIVE TO BE A RESULT OF THE ADAPTOR THAT WAS USED. PER THE ADVICE OF TECHNICAL SERVICES DURING THE PREVIOUS REPORT, THE MANUFACTURER REPRESENTATIVE UTILIZED THE OTHER LEAD. THE HCP PLANNED TO DISCONNECT THE LEAD THAT WAS NOT FUNCTIONING AND WORK BACKWARDS TO TROUBLESHOOT THE ISSUE. IT WAS CONFIRMED THAT THERE WAS NO IMPACT TO THE PATIENT. IT WAS CLARIFIED THAT THE PATIENT HAD BEEN WITHOUT STIMULATION FOR 2 YEARS AND WAS HAPPY TO HAVE SOME TYPE OF STIMULATION TO HELP WITH THE PAIN. NO FURTHER COMPLICATIONS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3887-45, LOT# J0340670V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD. PRODUCT ID: 3986ILC, LOT# N25820, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE CONCERNING PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR OTHER CHRONIC/INTRACT PAIN (TRUNK/LIMBS). IT WAS REPORTED THAT INTRA-OPERATIVELY IMPEDANCES WERE >10,000. INTRA-OPERATIVELY THE PHYSICIAN MOVED ONE DUAL PRONG TO THE OTHER PORT OF POCKET ADAPTER AND HAD THE SAME RESULT. THE REPRESENTATIVE SWITCHED REFERENCE ELECTRODES TO 4 WHICH RESOLVED THE >10,000 OHMS. IT WAS DISCUSSED THAT 45, 56, 67 WERE THE BEST COMBINATIONS TO TRY WHEN PROGRAMMING. IT WAS UNKNOWN IF THE PATIENT COULD FEEL STIMULATION ON THAT SIDE YET. IT WAS DISCUSSED THAT OLDER LEADS HAVE A HIGHER CHANGE OF FRACTURES, ETC. THE REPRESENTATIVE CALLED BACK WHILE THE PATIENT WAS IN THE POST-OP AREA. THEY SWITCHED PORTS TO TEST LEAD AND SINCE THINGS RESOLVED, THEY MADE THE DECISION TO CLOSE. THE REPRESENTATIVE WAS REPORTING THAT THE PATIENT FEELS STIMULATION 0-3 CONTACTS BUT DOES NOT FEEL ANY STIMULATION ON 4-7 CONTACTS. THE REPRESENTATIVE TRIED 4/5, 5/6, 6/7 WITH THE + OR ¿ MOVED TO DIFFERENT CONTACTS WITH NO CHANGE. THE REPRESENTATIVE INCREASED STIMULATION UP TO ¿MAX¿ AND STILL NO STIMULATION. THE PATIENT HAD LAST FELT STIMULATION 2 YEARS AGO. IT WAS REVIEWED WITH THE REP TO TRY SETTING UP STIMULATION TO RUN FOR 15-20 MINUTES AND RETEST ELECTRODE AND THERAPY IMPEDANCES TO SEE IF THERE IS ANY CHANGE AND TO SEE IF THE PATIENT FEELS STIMULATION OVER TIME. IT WAS REVIEWED THAT BASED ON THE VALUES BEING REPORTED, IT WAS EXPECTED THE PATIENT WOULD FEEL STIMULATION. REVIEWED TO CONFIRM LEAD IS STILL IN THE CORRECT LOCATION, REVIEWED POSSIBLE SCAR TISSUE GROWTH MAY BE IMPEDING THE CURRENT FROM GETTING THROUGH TO THE SPINAL CORD. THE REP WAS GOING TO TRY STIMMING FOR A WHILE TO SEE IF THERE WERE ANY CHANGES IN STIMULATION. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801127 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention