BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 10844563 · Received November 16, 2020

    Report

    Report Number
    2182207-2020-01279
    Event Type
    Injury
    Date Received
    November 16, 2020
    Date of Event
    April 7, 2020
    Report Date
    November 16, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. 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. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: 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

    GUPTA, A., KINMAN, C., HOBSON, D. T. G., MERIWETHER, K. V., GASKINS, J. T., UDDIN, N., STEWART, R., FRANCIS, S. L. THE IMPACT OF FLUOROSCOPY DURING PERCUTANEOUS NERVE EVALUATION ON SUBSEQUENT IMPLANTATION OF A SACRAL NEUROMODULATOR AMONG WOMEN WITH PELVIC FLOOR DISORDERS: A RANDOMIZED, NONINFERIORITY TRIAL. NEUROMODULATION. 2020. DOI: 10.1111/NER.13164. SUMMARY: TO EVALUATE WHETHER PERCUTANEOUS NERVE EVALUATION (PNE) WITHOUT FLUOROSCOPY IS INFERIOR TO FLUOROSCOPY USE IN WOMEN UNDERGOING TRIALS OF SACRAL NEUROMODULATION (SNM) FOR PELVIC FLOOR DISORDERS (PFDS). IN AN UNBLINDED NONINFERIORITY TRIAL, WOMEN UNDERGOING PNE WERE RANDOMIZED TO FLUOROSCOPY OR NO FLUOROSCOPY. THE PRIMARY OUTCOME WAS ¿SUCCESS¿ AND DEFINED AS IMPLANTATION OF THE PERMANENT SNM DEVICE WITHIN THREE MONTHS OF PNE. AT AN EXPECTED 40% SUCCESS AND A 30% NONINFERIORITY THRESHOLD, 33 PARTICIPANTS IN EACH GROUP WERE NEEDED FOR 80% POWER ( = 0.05). UNIVARIATE ANALYSES AND A LOGISTIC REGRESSION MODEL ADJUSTING FOR UNIVARIATE VARIABLES ASSOCIATED WITH THE PRIMARY OUTCOME WERE PERFORMED. FROM APRIL 2016 TO DECEMBER 2018, 74 PARTICIPANTS UNDERWENT PNE OF WHICH 36 UNDERWENT PNE WITH FLUOROSCOPY AND 38 WITHOUT. THE FLUOROSCOPY GROUP HAD LESS BASELINE MEAN DAILY VOIDS COMPARED TO THE NO FLUOROSCOPY GROUP (10.79 _ 6.48 VS. 16.21 _ 10.05, P = 0.01). PNE PERFORMED WITHOUT FLUOROSCOPY HAD SIMILAR SUCCESS (18/38, 47.4%) COMPARED TO FLUOROSCOPY (21/36, 58.3%), MEETING OUR NONINFERIORITY DEFINITION (DIFFERENCE 10.9%, 90% CI -8% TO 30%, P = 0.049). IN A LOGISTIC REGRESSION MODEL ADJUSTING FOR AGE, CHARLSON COMORBIDITY INDEX, STAGE OF PROLAPSE, AND NUMBER OF BASELINE VOIDS PER DAY, TRIAL SUCCESS WAS STILL SIMILAR BETWEEN THE TWO GROUPS (ADJOR 1.82, 95% CI 0.52 TO 6.94, P = 0.36). PNE PERFORMED WITHOUT FLUOROSCOPY IS NONINFERIOR TO PNE WITH FLUOROSCOPY USE FOR THE OUTCOME OF SNM DEVICE IMPLANTATION WITHIN THREE MONTHS AMONG WOMEN UNDERGOING THERAPY FOR PFDS. REPORTED EVENTS: ONE PATIENT IN THE FLUOROSCOPY GROUP EXPERIENCED A PREMATURE REMOVAL. ONE PATIENT IN THE NON-FLUOROSCOPY GROUP EXPERIENCED A PREMATURE REMOVAL. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313213 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention