BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 12356686 · Received August 23, 2021

    Report

    Report Number
    2182207-2021-01461
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Date of Event
    February 15, 2021
    Report Date
    August 23, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL#: UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INTERSTIM_INS, SERIAL#: 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

    MASOOD. I., CHEN. Q., LI. J, ET AL. SACRAL NEUROMODULATION IN PATIENTS WITH NEUROGENIC LOWER URINARY TRACT DYSFUNCTION: A MULTICENTER RETROSPECTIVE STUDY FROM CHINA. NEUROMODULATION. 2021. DOI: 10.1111/NER.13383 SUMMARY: THIS RETROSPECTIVE STUDY AIMED TO DETERMINE THE EFFECTIVENESS OF SACRAL NEUROMODULATION (SNM) ON NEUROGENIC LOWER URINARY TRACT DYSFUNCTION (NLUTD) AND ANALYZE THE PREDICTIVE FACTORS. MATERIALS AND FROM JANUARY 2012 TO JANUARY 2020, 152 SUBJECTS WITH NLUTD FROM FOUR MEDICAL CENTERS IN CHINA RECEIVED SNM TEST STIMULATION. SUBJECTS WERE ASSESSED VIA BLADDER DIARIES, POSTVOID RESIDUAL VOLUMES (PRVS) AND NEUROGENIC BOWEL DYSFUNCTION (NBD) SCORES BEFORE AND DURING THE TESTING PERIOD. PATIENTS WHO SHOWED A MINIMUM 50% IMPROVEMENT IN SYMPTOMS THROUGH THE SNM TEST PHASE WERE ELIGIBLE FOR PERMANENT SNM IMPLANTATION. THE POOLED SUCCESS RATE FOR CHRONIC URINARY RETENTION WAS 31.0% (40/129), WHICH WAS SIGNIFICANTLY LOWER (P <(><<)> 0.05) THAN THE RATES FOR FREQUENCY-URGENCY (64.8%, 59/91), URINARY INCONTINENCE (65.2%, 30/46), AND NBD SCORE (61.7%, 82/133). THE RESULTS OF THE RISK FACTOR ANALYSIS SHOWED THAT THE URINARY STORAGE SYMPTOM WAS A STATISTICALLY SIGNIFICANT POSITIVE PREDICTOR (P = 0.001). IN CONCLUSION, SNM IS AN EFFECTIVE AND RELIABLE METHOD FOR TREATING NLUTD, ESPECIALLY IN PATIENTS WITH URINARY STORAGE SYMPTOMS. ALTHOUGH NOT ALL OF THE SYMPTOMS IN EVERY PATIENT CAN BE RESOLVE, SNM STILL MIGHT BE A SUPERIOR CHOICE TOGETHER WITH OTHER TREATMENT PROCEDURES. REPORTED EVENT: 1: FOUR PATIENTS WITH ELECTRODE DISLOCATION. 2: THREE PATIENTS WITH IPG FAILURE. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252214 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1