BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 13543746 · Received February 16, 2022

    Report

    Report Number
    2182207-2022-00268
    Event Type
    Injury
    Date Received
    February 16, 2022
    Date of Event
    November 20, 2020
    Report Date
    February 16, 2022
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MSIKA, J., KALANTAN, M., LARRE, S., LEON, P. FUNCTIONAL RESULTS AND SATISFACTION IN 44 PATIENTS AFTER IMPLANTATION OF A NS3-TYPE SACRAL NEUROSTIMULATOR FOR REFRACTORY IDIOPATHIC OVERACTIVE BLADDER FOLLOWED AT 43 MONTHS, SINGLE-CENTER SERIES. PROG UROL. DOI: 2021.1 0.1016/J.PUROL.2020.11.007. SUMMARY: SACRED NEUROMODULATION (SNM) HAS BEEN USED IN (B)(6) SINCE 1997 FOR THE MANAGEMENT OF NON-NEUROGENIC URINARY DISORDERS THAT DO NOT RESPOND TO FIRST-LINE PHARMACOLOGICAL TREATMENT. THE AIM OF THIS STUDY IS TO ANALYZE THE CLINICAL EFFICACY AND SATISFACTION OF PATIENTS WITH REFRACTORY IDIOPATHIC OVERACTIVE BLADDER (OAB) TREATED WITH SNM. THIS SINGLE-CENTER RETROSPECTIVE SERIES INCLUDED 59 PATIENTS WITH REFRACTORY OAB OF IDIOPATHIC ORIGIN AND ELIGIBLE FOR THE SNM BETWEEN JANUARY 2010 AND DECEMBER 2017. DEMOGRAPHIC DATA, HISTORY OF PELVIC SURGERY, COMPLICATIONS ACCORDING TO CLAVIEN-DINDO CLASSIFICATION, AS WELL AS REVISION AND EXPLANTATION RATES WERE COLLECTED. ALL THE PATIENTS INCLUDED UNDERWENT A TEST PHASE. THERAPEUTIC SUCCESS FOR THE TEST PHASE AND DEFINITIVE IMPLANTATION WAS DEFINED BY = 50% IMPROVEMENT. SATISFACTION WAS A SECONDARY CRITERIA. OF THE 59 PATIENTS TESTED FOR SNM, 44 PATIENTS HAD A PERMANENT IMPLANTATION, OF WHICH 36 (82%) WERE WOMEN AND 8 (12%) WERE MEN. THE MEDIAN AGE OF THE STUDY WAS 55 YEARS OLD. THE MEDIAN FOLLOW-UP WAS 43 MONTHS [21,2¿66,5]. ALL OF THE PATIENTS HAD AN IDIOPATHIC REFRACTORY OAB. THE MEDIAN TIME BETWEEN TEST AND FINAL IMPLANTATION WAS 28 DAYS [18¿35]. THE SUCCESS RATE FOR ALL PATIENTS TESTED WAS 60% (34/59). IN PATIENTS IMPLANTED, 34 PATIENTS (77%) HAD C LINICAL IMPROVEMENT. ADVERSE EVENTS HAD TO BE MANAGED INCLUDING MULTIPLE REPARAMETERIZATIONS (N = 13), DEVICE REVISION (N = 16), OR EVEN DEVICE IMPLANTATION (N = 8). THE SATISFACTION RATE WAS 82% (36/44). WITH A MEDIAN FOLLOW-UP OF 43 MONTHS, THIS RETROSPECTIVE STUDY ON NMS SHOWS THE EFFICACY OF SECOND-LINE SNM FOR IDIOPATHIC OAB. THIS TECHNIQUE REMAINS MINIMALLY INVASIVE BUT WITH SIGNIFICANT ADVERSE EVENTS WHEN INFORMING OUR PATIENTS. REPORTED EVENTS: ONE PATIENT EXPERIENCED LOCAL PAIN AT THE SURGICAL SITE AND THEIR DEVICE WAS REMOVED. 2 PATIENTS EXPERIENCED AN INFECTION AND THEIR DEVICE WAS REMOVED. ONE PATIENT EXPERIENCED RECTAL PAIN AND THEIR DEVICE WAS REMOVED. NO SPECIFIC DEVICE INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9905 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention