BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 13578447 · Received February 22, 2022

    Report

    Report Number
    2182207-2022-00311
    Event Type
    Malfunction
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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: FAILURE OCCURRED IN TWO PATIENTS WITH IUR (IDIOPATHIC NON-OBSTRUCTIVE URINARY RETENTION) AT THREE AND 47 MONTHS AFTER IMPLANTATION. NO SPECIFIC DEVICE INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905227 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown