BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 10862233 · Received November 18, 2020

    Report

    Report Number
    2182207-2020-01295
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    July 9, 2020
    Report Date
    November 18, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    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, 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. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    KAAKI, B., GUPTA, D. MEDIUM-TERM OUTCOMES OF SACRAL NEUROMODULATION IN PATIENTS WITH REFRACTORY OVERACTIVE BLADDER: A RETROSPECTIVE SINGLE-INSTITUTION STUDY. PLOS ONE. 2020. 15(7):E0235961. DOI: 10.1371/JOURNAL.PONE.0235961 SUMMARY: SACRAL NEUROMODULATION (SNM) IS A MINIMALLY INVASIVE FULLY REVERSIBLE THERAPY THAT WAS APPROVED IN 1997 FOR OVERACTIVE BLADDER SYNDROME (OAB) REFRACTORY TO BEHAVIOR MODIFICATION AND PHARMACOTHERAPY. DESPITE BEING IN USE FOR OVER TWO DECADES, THE DATA ON MEDIUM TO LONG-TERM SAFETY AND EFFICACY OF SNM IN OAB IS LIMITED. WE INVESTIGATED THE MEDIUM-TERM EFFICACY AND SAFETY OF SNM ALONG WITH THE PREDICTIVE FACTORS FOR ITS SUCCESS IN PATIENTS WITH REFRACTORY OAB. A RETROSPECTIVE CONSECUTIVE CASE SERIES OF 66 PATIENTS UNDERGOING SNM FOR REFRACTORY OAB BETWEEN JULY 2009 AND JULY 2018. ALL PATIENTS UNDERWENT A TEST PERIOD FOLLOWED BY PERMANENT IMPLANTATION, IF THERE WAS > = 50% IMPROVEMENT IN ANY SYMPTOM. THE PRIMARY OUTCOME WAS ¿SUCCESS¿ DEFINED AS > = 50% IMPROVEMENT IN ANY CLINICAL PARAMETER BASED ON THE SUBJECTIVE ASSESSMENT OF PATIENT¿S RESPONSE. THE SECONDARY OUTCOMES WERE NUMBER OF PADS USED IN 24 HOURS, POST-OPERATIVE COMPLICATIONS AND RE-OPERATION RATES. 66 FEMALES WITH AN AVERAGE AGE OF 62.7 YEARS WERE INCLUDED. 55/66 PATIENTS (83.3%) HAD A SUCCESSFUL TEST PHASE AND UNDERWENT PERMANENT IMPLANTATION. AFTER A MEDIAN FOLLOW-UP OF 32 MONTHS, SNM WAS SUCCESSFUL IN 41/55 (74.5%) PATIENTS. MEAN NUMBER OF PADS USED IN 24 HOURS DECREASED SIGNIFICANTLY FROM 3.5 PREOPERATIVELY TO 1.2 AT LAST FOLLOW-UP (P<(><<)>0.001). 8/55 (14.5%) PATIENTS REPORTED COMPLICATIONS OF PAIN, LEAD MIGRATION, WOUND DEHISCENCE AND DEVICE MALFUNCTION. 10/55 (18.2%) PATIENTS UNDERWENT REVISION SURGERIES AFTER A MEDIAN DURATION OF 21.9 MONTHS. DEVICE WAS EXPLANTED IN 15/55 (27.3%) PATIENTS AFTER A MEDIAN DURATION OF 24 MONTHS. NO SIGNIFICANT PREDICTOR FOR SUCCESS WAS IDENTIFIED. THE SUCCESS RATE OF SNM IS 75% WITH A COMPLICATION RATE OF 14.5% AFTER A MEDIAN FOLLOW-UP OF ~3 YEARS. THIS STUDY SUGGESTS MEDIUM-TERM EFFICACY AND SAFETY BUT A HIGH RE-OPERATION RATE OF SNM IN PATIENTS WITH REFRACTORY OAB. REPORTED EVENTS: ONE PATIENT EXPERIENCED AN INFECTION/WOUND DEHISCENCE. 5 PATIENTS WITH DECREASED DEVICE EFFICACY WERE CONSIDERED THERAPEUTIC FAILURES AND UNDERWENT EXPLANTATION AFTER A MEDIAN OF 24 MONTHS (RANGE 11¿29 MONTHS) FROMTHE DATE OF PERMANENT IMPLANT. NO SPECIFIC DEVICE INFORMATION PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325143 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention