BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 10823534 · Received November 11, 2020

    Report

    Report Number
    2182207-2020-01258
    Event Type
    Malfunction
    Date Received
    November 11, 2020
    Date of Event
    April 27, 2020
    Report Date
    November 11, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VAGANEE, D., VAN DE BORNE, S., VOORHAM-VAN DER ZALM, P., VOORHAM, J., FRANSEN, E., DE WACHTER, S. PELVIC FLOOR MUSCLE ELECTROMYOGRAPHY AS A GUIDING TOOL DURING LEAD PLACEMENT AND (RE)PROGRAMMING IN SACRAL NEUROMODULATION PATIENTS: VALIDITY, RELIABILITY, AND FEASIBILITY OF THE TECHNIQUE. NEUROMODULATION. DOI: 2020. 10.1111/NER.13177 SUMMARY: TO ASSESS THE VALIDITY, RELIABILITY, AND FEASIBILITY OF ELECTROMYOGRAPHY (EMG) AS A TOOL TO MEASURE PELVIC FLOOR MUSCLE (PFM) CONTRACTIONS DURING PLACEMENT AND (RE)PROGRAMMING OF THE TINED LEAD ELECTRODES IN SACRAL NEUROMODULATION (SNM) PATIENTS. SINGLE TERTIARY CENTER, PROSPECTIVE STUDY CONDUCTED BETWEEN 2017 AND 2019 CONSISTING OF THREE PROTOCOLS INCLUDING A TOTAL OF 75 PATIENTS WITH OVERACTIVE BLADDER (WET/DRY) OR NONOBSTRUCTIVE URINARY RETENTION. PFM EMG WAS RECORDED USING THE MULTIPLE ARRAY PROBE (MAPLE), PLACED INTRAVAGINALLY. ALL STIMULATIONS (MONOPHASIC PULSED SQUARE WAVE, 210 ¿SEC, 14 HZ) WERE PERFORMED USING MEDTRONIC¿S STANDARD SNM STIMULATION EQUIPMENT. DURING LEAD IMPLANTATION, ALL FOUR LEAD ELECTRODES WERE STIMULATED WITH FIXED INCREASING STIMULATION INTENSITIES (1-2-3-5-7-10 V). DURING LEAD ELECTRODE (RE)PROGRAMMING, FIVE BIPOLAR LEAD ELECTRODE CONFIGURATIONS WERE STIMULATED TWICE UP TO WHEN AN ELECTRICAL PFM MOTOR RESPONSE (EPFMR), SENSORY RESPONSE, AND PAIN RESPONSE WERE NOTED (I.E., THE THRESHOLD), RESPECTIVELY. ADDITIONALLY, AMPLITUDE AND LATENCY OF THE EPFMRS WERE DETERMINED. VALIDITY, RELIABILITY, AND FEASIBILITY WERE STATISTICALLY ANALYZED USING THE INTRACLASS CORRELATION COEFFICIENT, WEIGHTED COHEN¿S KAPPA AND LINEAR REGRESSION, RESPECTIVELY. RESULTS: VALIDITY: EPFMRS WERE STRONGLY ASSOCIATED WITH VISUALLY DETECTED PFM MOTOR RESPONSES (¿ = 0.90). RELIABILITY: EPFMR AMPLITUDE (ICC = 0.99) AND LATENCY (ICC = 0.93) SHOWED EXCELLENT REPEATABILITY. FEASIBILITY: LINEAR REGRESSION (EPFMR THRESHOLD = 0.18 MA + 0.76 * SENSORY RESPONSE THRESHOLD) SHOWED AN INCREASE IN THE SENSORY RESPONSE THRESHOLD IS ASSOCIATED WITH A SMALLER INCREASE IN EPFMR THRESHOLD, WITH THE EPFMR OCCURRING BEFORE OR ON THE SENSORY RESPONSE THRESHOLD IN 83.8% OF ALL STIMULATIONS. MEASURING PFM CONTRACTIONS WITH EMG DURING PLACEMENT AND (RE)PROGRAMMING OF LEAD ELECTRODES IN SNM PATIENTS IS VALID, RELIABLE, AND FEASIBLE. THEREFORE, THE USE OF PFM EMG MOTOR RESPONSES COULD BE CONSIDERED AS A TOOL TO ASSIST IN THESE PROCEDURES. REPORTED EVENTS: 1. 2 PATIENTS, WITH FOUR AND TWO LEAD ELECTRODE CONFIGURATIONS WERE EXCLUDED DUE TO AN IMPEDANCE OF EITHER <(><<)>50 O OR > 4000 O. 2. ANOTHER INTERESTING ASPECT IS THAT ALL THREE PATIENTS HAD A (BORDERLINE) SUCCESSFUL TEST PROCEDURE BUT AFTER IMPLANTATION OF THE DEFINITIVE BATTERY SHOWED A FAST (WITHIN SIX MONTHS) DECLINE IN CLINICAL EFFICACY. SEE ATTACHED LITERATURE ARTICLE. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291110 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1