BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 9434390 · Received December 6, 2019

    Report

    Report Number
    3007566237-2019-02495
    Event Type
    Malfunction
    Date Received
    December 6, 2019
    Report Date
    March 11, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    H3 CORRECTION: PLEASE NOTE THAT SECTIONS B1, D3, D4, AND H4 HAVE BEEN UPDATED AT THIS TIME BASED ON ADDITIONAL INFORMATION THAT HAS BEEN RECEIVED. H6: PLEASE NOTE THAT DEVICE CODES C62917 AND C63184 NO LONGER APPLY TO THIS REPORT. ADDITIONALLY, PATIENT CODE C50526 NO LONGER APPLIES. 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

    IT WAS REPORTED THAT ONE PATIENT EXPERIENCED A BACK-PAIN FLARE THAT WAS REPORTED AT THEIR 18-WEEK FOLLOW-UP. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS REPORTED TO HAVE EXPERIENCED OVERSTIMULATION DURING THEIR DEVICE TRIAL AND ALSO OVERSTIMULATION THAT WAS OBSERVED AT THEIR 26 WEEK FOLLOW-UP. THE 18-WEEK FOLLOW-UP BACK-PAIN FLARE WAS NOTED TO HAVE OCCURRED ON (B)(6) 2019. THE CAUSE OF THE BACK-PAIN FLARE WAS DETERMINED TO BE AN "ACUTE FLARE-UP OF DIFFUSE IDIOPATHIC SKELETAL HYPEROSTOSIS (DISH)." IT WAS FURTHER STATED THAT THE PATIENT HAD NOT EXPERIENCED OVERSTIMULATION AND THAT INSTEAD IT WAS "PAIN ASSOCIATED WITH AN ACUTE FLARE-UP OF DISH PAIN. THE PATIENT RECEIVED THE FOLLOWING INTERVENTIONS AS A RESULT OF THE EVENT: "HOSPITALIZATION, SPECT CT, PRESCRIPTION PAIN MEDICATIONS, AND NEUROSURGEON REVIEW." THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED. PLEASE NOTE THAT BASED ON ADDITIONAL INFORMATION THAT HAS BEEN RECEIVED, THIS REPORT NOW APPLIES ONLY TO THE INITIALLY REPORTED EVENT #1. PLEASE SEE REGULATORY REPORT #6000030-2020-00122 FOR INFORMATION REGARDING EVENT 2 AND REGULATORY REPORT #6000030-2020-00123 FOR INFORMATION REGARDING EVENTS 3 AND 4.

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE ((B)(6) YEARS) OF THE PATIENTS IN THE STUDY AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE SEX OF THE MAJORITY OF THE PATIENTS IN THE STUDY AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE IS THE AVERAGE WEIGHT (94.92 KG) OF THE PATIENTS IN THE STUDY AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENTS WITH PREVIOUSLY REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_ENS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR. PRODUCT ID: 97715, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, UBD: ASKU, UDI#: ASKU. G3 COUNTRY: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    REPORTED EVENTS: 1 PATIENT EXPERIENCED A BACK-PAIN FLARE THAT WAS REPORTED AT THEIR 18-WEEK FOLLOW-UP. 1 PATIENT EXPERIENCED LEAD MIGRATION DURING THEIR TRIAL. IT WAS NOTED THE TRIAL WAS CONSIDERED A FAILED TRIAL. 1 PATIENT EXPERIENCED LEAD MIGRATION THAT WAS OBSERVED AT THEIR 10-WEEK FOLLOW-UP. 1 PATIENT EXPERIENCED LEAD MIGRATION THAT WAS OBSERVED AT THEIR 18-WEEK FOLLOW-UP. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224723 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR