BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 8152248 · Received December 11, 2018

    Report

    Report Number
    3007566237-2018-03565
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    December 5, 2018
    Report Date
    December 19, 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 977D260 LOT# SERIAL# (B)(4) PRODUCT TYPE SCREENING DEVICE PRODUCT ID 977D260 LOT# SERIAL# (B)(4) PRODUCT TYPE SCREENING DEVICE. 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 A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT NOTHING WAS DETERMINED. THE REP REPORTED THAT THE PHYSICIAN HAD A THEORY OF SCAR TISSUE ON A NERVE, BUT NOTHING HAD BEEN DETERMINED. THE REP REPORTED THAT THE PATIENT STATED THE SHOCKING AND SEVERE TOE/FOOT PAIN HAD NOT RESOLVED. THE REP REPORTED THAT THE PATIENT NOW SAID HE HAD PLANTAR FASCIITIS FROM THE PHYSICIAN AND PROCEDURE. THE REP REPORTED THAT THE PHYSICIAN PRESCRIBED GABAPENTIN FOR NERVE PAIN AND TOROIDAL AFTER SURGERY (B)(6) 2018. THE PATIENT EXPLAINED THAT IT HELPED BUT WORE OFF. THE REP REPORTED THAT A FOLLOW UP REPROGRAM WAS DONE ON (B)(6) 2018 TO HELP PAIN MAP OUT HIS FOOT BETTER, WHILE ALSO TRYING TO HELP IMPROVE STIMULATION IN HIS BACK. THE REP REPORTED THAT THE PATIENT SAID HE WAS GETTING 25% RELIEF, BUT EXPLAINED HE WAS VERY UPSET WITH THE PHYSICIAN AND THOUGHT THE PHYSICIAN HAD MESSED UP. THE REP REPORTED THAT THE LEAD PULL WAS (B)(6) 2018. THE PATIENT THEN SAID HIS PAIN WAS ¿PLANTAR FASCIITIS¿ (UNDIAGNOSED) THAT THE PHYSICIAN GAVE HIM FROM THE PROCEDURE AND THEN SAID HE WAS TAKING FURTHER ACTIONS. THE REP REPORTED THAT THE PHYSICIAN WAS STILL UNSURE WHAT, IF ANYTHING ACTUALLY HAPPENED. THE REP REPORTED THAT AN X-RAY WAS TAKEN AFTER COMPLETION OF THE PROCEDURE AND NOTHING WAS SEEN TO BE ABNORMAL. NO FURTHER COMPLICATIONS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. 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 (REP) REGARDING A TRIAL PATIENT WITH A EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED THAT WHEN THE HEALTHCARE PROFESSIONAL (HCP) PLACED THE TRIAL LEAD, THE PATIENT JUMPED OFF THE TABLE AND COMPLAINED OF FOOT PAIN ON THEIR LEFT FOOT AND FOURTH TOE. THE PATIENT REPORTED SHOCKING AND INTENSE PAIN IN THE LEFT TOE AND PROCEEDED TO CRAWL ON THE GROUND. THE REP NOTED THAT THEY HELPED CALM DOWN THE PATIENT BY RUBBING THEIR TOE AS A "HUMAN RESPONSE". WHEN THE REP STOPPED THE PATIENT STARTED TO COMPLAIN OF PAIN AGAIN AND SO THE REP WAS ENCOURAGED TO KEEP RUBBING THE PATIENT'S TOE TO KEEP THEM STILL. THE HCP DID USE FLUORO WHILE PLACING THE LEAD AND TESTED WITH A LOSS OF RESISTANCE SYRINGE. THE REP STATED THAT AN MRI AND X-RAY DID NOT INDICATE ANY ISSUES AND EVERYTHING WAS PLACED ACCURATELY. THE HCP BELIEVED THAT THERE MAY HAVE BEEN SCAR TISSUE OR SPINAL ANOMALY ATTACHED TO A NERVE ROOT AND WHEN LEAD WAS PLACED THIS COULD HAVE SEPARATED IT FROM THE NERVE. THE REP MET WITH THE PATIENT ON (B)(6) AND TRIED TO REPROGRAM AND STEER THE THERAPY TOWARDS THE PATIENT'S TOE. THE REP SAID THE PATIENT WAS PANTING EVEN WITH THE RAPY OFF. THE REP MAPPED OUT THE PATIENT'S TOE PAIN AS BEST THEY COULD, ADJUSTED FOR HIGHER IN THE PATIENT'S BACK PER THE PATIENT'S REQUEST AND GAVE THE PATIENT OPTIONS AND THE PATIENT PICKED THE PROGRAM THEY LIKED BEST. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993418 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 97725

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention