BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 11866547 · Received May 21, 2021

    Report

    Report Number
    2182207-2021-00869
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    January 5, 2021
    Report Date
    May 21, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: DE ANDRES J, FORMICOLA GL, RUBIO-HARO R, DE ANDRES-SERRANO C. UPDATED MANAGEMENT OF OCCIPITAL NERVE STIMULATOR LEAD MIGRATION: CASE REPORT OF A TECHNICAL CHALLENGE. SCANDINAVIAN JOURNAL OF PAIN. 2021;0(0). 10.1515/SJPAIN-2020-0135 LITERATURE ABSTRACT: ELECTRODE MIGRATION IS A CHALLENGE, EVEN WITH ADEQUATE ANCHORING TECHNIQUES, DUE TO THE HIGH MECHANICAL STRESS ON COMPONENTS OF OCCIPITAL NERVE STIMULATION (ONS) FOR HEADACHE DISORDERS. WHEN A LEAD DISPLACEMENT OF AN ONS IMPLANT IS DIAGNOSED, THERE ARE CURRENTLY DIFFERENT APPROACHES DESCRIBED FOR ITS MANAGEMENT. NEVERTHELESS CURRENT NEUROMODULATION DEVICES ARE DESIGNED LIKE A CONTINUUM OF COMPONENTS WITHOUT ANY INTERMEDIATE CONNECTOR, AND IF A LEAD DISPLACEMENT IS DIAGNOSED, THE SOLUTION IS THE COMPLETE REMOVAL OF THE ELECTRODE FROM ITS PLACEMENT, AND ITS REPOSITIONING THROUGH AN EX-NOVO PROCEDURE. THE DESCRIBED TECHNIQUE CAN ALLOW ONS LEADS TO BE REVISED WHILE MINIMIZING THE NEED TO REOPEN INCISIONS OVER THE IPG, THUS IMPROVING PATIENTS INTRAOPERATIVE AND POSTOPERATIVE DISCOMFORT, SHORTENING SURGICAL TIME AND MEDICAL COSTS, REASONABLY REDUCING THE INCIDENCE OF INFECTIVE POSTOPERATIVE COMPLICATIONS. PLEASE NOTE THIS DATE IS BASED OFF OF THE ARTICLES PUBLICATION DATE AS THE SPECIFIC EVENT DATE WAS NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENTS WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A275, LOT# UNKNOWN, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977A275, SERIAL/LOT #: UNKNOWN. DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS OCCIPITAL NERVE STIMULATION TO TREAT LONG-TERM CERVICOGENIC HEADACHE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT WAS REFERRED DUE TO BILATERAL ARNOLD NEURALGIA AND LONG-TERM CERVICOGENIC HEADACHE. SHE WAS REFRACTORY TO PHARMACOLOGICAL TREATMENT AND REPEATED MINIMALLY INVASIVE TECHNIQUES ON DORSAL ROOT GANGLIA AND TERMINAL BRANCHES OF C2C3. THE PATIENT THEN SUCCESSFULLY UNDERWENT A TRIAL OF SUBCUTANEOUS OCCIPITAL NERVE STIMULATION (ONS) AND PROCEEDED TO RECEIVE A PERMANENT IMPLANTABLE NEUROSTIMULATOR (INS). HOWEVER, AFTER A 30 DAYS USE PERIOD, A DIFFERENCE IN CLINICAL EFFECTIVENESS WAS OBSERVED BETWEEN THE LEFT AND RIGHT LEAD, WITH BETTER CONTROL OF SYMPTOMS ON THE RIGHT SIDE. REPROGRAMMING WAS ATTEMPTED WITHOUT SUCCESS, SO IT WAS DECIDED TO RESCHEDULE THE PATIENT FOR LEFT ELECTRODE REPOSITIONING UNDER MONITORED SEDATION. THE SURGICAL TEAM USED A NONSPECIFICALLY, DESIGNED FOR THE PROCEDURE, PEEL-AWAY INTRODUCER THROUGH A SIMPLE MEDIAN OCCIPITAL INCISION IN ORDER REPOSITION THE PATIENTS LEFT LEAD. THE WHOLE SYSTEM WAS THEN TESTED AND CONFIRMED BY THE PATIENT TO BE IN SATISFACTORY WORKING CONDITION. THE LEAD WAS THEN ANCHORED FOR AVOIDING DISLODGEMENTS; LAYERED WOUND CLOSURE WITH ABSORBABLE SUTURE AND SKIN CLOSURE WITH INTRADERMAL SYNTHETIC ABSORBABLE SUTURE, WERE COMPLETED. THE PATIENT WAS TRANSPORTED TO RECOVERY AND DISCHARGED ONE DAY AFTER FROM THE HOSPITAL. THE PATIENT WAS SEEN IN THE OFFICE 10 DAYS AND SIX MONTHS AFTER THE PROCEDURE WITH NO COMPLICATIONS AND TOTAL SATISFACTION WITH THE RESULT. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761585 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 97715 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| R