BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 10919844 · Received November 30, 2020

    Report

    Report Number
    2182207-2020-02987
    Event Type
    Injury
    Date Received
    November 30, 2020
    Date of Event
    July 24, 2020
    Report Date
    November 30, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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. PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. 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

    WAGNER, L., ALONSO, S., LE NORMAND, L., FAIX, A., KABANI, S., CASTELLI, C., GAME, X., CORNU, J. N., BEY, E.. UNILATERAL VERSUS BILATERAL SACRAL NEUROMODULATION TEST IN THE TREATMENT OF REFRACTORY IDIOPATHIC OVERACTIVE BLADDER: A RANDOMIZED CONTROLLED PILOT TRIAL. NEUROUROL URODYN. 2020. 39(8). DOI: 2230-2237. 10.1002/NAU.24476. SUMMARY: TO COMPARE TREATMENT SUCCESS RATE IN TERMS OF IMPROVEMENT OF BLADDER OVERACTIVITY BETWEEN UNILATERAL AND BILATERAL SACRAL NEUROMODULATION TESTING. METHODS: A MULTICENTRIC, PARALLEL, RANDOMIZED, OPEN PILOT TRIAL (OCTOBER 2012-SEPTEMBER 2017) WAS CONDUCTED. PARTICIPANTS PRESENTED PRIMARY OVERACTIVE BLADDER RESISTANT TO FIRST-LINE TREATMENTS. PATIENTS WERE EXCLUDED IN CASE OF SECONDARY B LADDER, PELVIC, OR NEUROLOGICAL CONDITION. PATIENTS WERE RANDOMIZED BETWEEN BILATERAL TESTING (N = 28) OR UNILATERAL TESTING (N = 27), TO DETERMINE THE BEST FUNCTIONAL RESPONSE BEFORE FINAL IMPLANTATION. THE PRIMARY OUTCOME WAS THE RATE OF PATIENTS PRESENTING AT LEAST 50% OF CLINICAL IMPROVEMENT AT 1 MONTH ON URINARY FREQUENCY, NUMBER OF URGE INCONTINENCE EPISODES OR NUMBER OF URINARY URGENCY EPISODES. SYMPTOM SEVERITY, IMPLANTATION SUCCESS RATE, UROFLOWMETRY, DEVICE TOLERANCE, COMPLICATIONS, AND QUALITY OF LIFE WERE ALSO ASSESSED. FIFTY-FIVE PATIENTS HAVE BEEN INCLUDED. THE RATE OF PATIENTS PRESENTING AT LEAST ONE SIGNIFICANT CLINICAL IMPROVEMENT AT MONTH 1 WAS 62% IN THE BILATERAL GROUP VERSUS 84% IN THE UNILATERAL GROUP (P = .0891), RR = 0.74 (0.51; 1.07). THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN BILATERAL AND UNILATERAL GROUPS IN TERMS OF IMPROVEMENT OF URINARY FREQUENCY (0% AND 17%; P =.1115), NUMBER OF URGE INCONTINENCE EPISODES (52% AND 63%; P = .4929) OR NUMBER OF URINARY URGENCY EPISODES (57% AND 74%; P=.2411). MORE COMPLICATIONS WERE REPORTED IN THE BILATERAL GROUP THAN IN THE UNILATERAL GROUP (9 [47%] VS 4 [16%], RESPECTIVELY; P=.0239). SYSTEMATIC BILATERAL SACRAL NEUROMODULATION TESTING BEFORE FINAL IMPLANTATION DID NOT APPEAR TO INCREASE SUCCESS RATE COMPARED WITH UNILATERAL STIMULATION IN THE TREATMENT OF OVERACTIVE BLADDER. REPORTED EVENTS: 2 PATIENTS HAD CLAVIEN III COMPLICATIONS AS FOLLOWING: RELOCATION OF STIMULATOR DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387963 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention