BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 13578378 · Received February 22, 2022

    Report

    Report Number
    2182207-2022-00310
    Event Type
    Injury
    Date Received
    February 22, 2022
    Date of Event
    May 4, 2021
    Report Date
    February 22, 2022
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ID NEU_INS_STIMULATOR LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID NEU_INS_STIMULATOR LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID NEU_INS_STIMULATOR LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    COGUPLUGIL, A. E., YILMAZ, S., TOPUZ, B., ZOR, M., KAYA, E., GÜRDAL, M. SACRAL NEUROMODULATION TREATMENT FOR NON-NEUROGENIC UROLOGICAL DISORDERS: EXPERIENCE OF A SINGLE CENTER IN TURKEY. JOURNAL OF UROLOGICAL SURGERY. 2021. 8(4):261-265. DOI: 10.4274/JUS.GALENOS.2 021.2021.0023 SUMMARY: WE EVALUATED THE SUCCESS RATE AND COMPLICATIONS OF SACRAL NEUROMODULATION (SNM) IN PATIENTS WITH NON-NEUROGENIC UROLOGICAL DISORDERS. WE RETROSPECTIVELY EVALUATED PATIENTS WITH AN OVERACTIVE BLADDER (OAB), BLADDER PAIN SYNDROME/INTERSTITIAL CYSTITIS (BPS/IC), AND IDIOPATHIC NON-OBSTRUCTIVE URINARY RETENTION (IUR), WHO UNDERWENT SNM BETWEEN 2015 AND 2020. SNM WAS RECOMMENDED FOR PATIENTS WITH OAB AND BPS/IC WHO PREVIOUSLY HAD UNSUCCESSFUL CONSERVATIVE AND MEDICAL THERAPIES AND BOTULINUM TOXIN INJECTIONS. SUCCESS WAS DEFINED AS MORE THAN 50% IMPROVEMENT IN CLINICAL SYMPTOMS OR VOIDING DIARY PARAMETERS IN PATIENTS WITH OAB; MORE THAN 50% IMPROVEMENT IN STORAGE SYMPTOMS OR SUBJECTIVE PAIN IMPROVEMENT OR IMPROVEMENT AFTER PAIN MEDICATIONS IN PATIENTS WITH BPS/IC; MORE THAN 50% REDUCTION IN URETHRAL CATHETERIZATION RATE IN PATIENTS WITH IUR. WE REVIEWED THE SUCCESS RATES AND COMPLICATIONS. TWENTY-FOUR PATIENTS UNDERWENT THE FIRST STAGE OF SNM AND 16 PATIENTS (66.6%) RECEIVED PERMANENT IMPLANTATION. TEN PATIENTS WERE FEMALE (62.5%) AND SIX WERE MALE (37.5%). THE MEAN AGE WAS 36.9 YEARS. SEVEN PATIENTS (43.7%) HAD OAB, THREE PATIENTS (18.7%) HAD BPS/IC, AND SIX PATIENTS (37.5%) HAD IUR. AFTER A MEAN FOLLOW-UP OF 42.3 MONTHS, THE OVERALL SUCCESS RATE WAS 87.5% FOR ALL INDICATIONS. THE SUCCESS RATE WAS 100%, 100%, AND 66.7% FOR OAB, BPS/IC, AND IUR, RESPECTIVELY. FOUR PATIENTS UNDERWENT SURGICAL REINTERVENTION: TWO HAD THEIR DEVICES REMOVED DUE TO FAILURE (50%), ONE HAD THEIR IMPLANTABLE PULSE GENERATOR (IPG) REPOSITIONED DUE TO SERIOUS PAIN (25%), AND ONE CHANGED IPG DUE TO MALFUNCTION (25%). SNM IS A SAFE AND EFFECTIVE MINIMALLY INVASIVE THERAPY FOR PATIENTS WITH NON-NEUROGENIC UROLOGICAL DISORDERS REPORTED EVENTS: 1. TWO PATIENTS EXPERIENCED DEVICE FAILURE AND HAD THEIR DEVICE REMOVED. 2. ONE PATIENT HAD IPG REPOSITIONED DUE TO SERIOUS PAIN AT THE IMPLANT SITE. 3 ONE PATIENT EXPERIENCED IPG MALFUNCTION AND HAD THEIR DEVICE CHANGED. NO SPECIFIC DEVICE INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005791 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention