BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 11252069 · Received January 29, 2021

    Report

    Report Number
    2182207-2021-00162
    Event Type
    Injury
    Date Received
    January 29, 2021
    Date of Event
    November 13, 2020
    Report Date
    January 29, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ALTOMARE, D. F., PICCIARIELLO, A., DI CIAULA, A., RINALDI, M., DE FAZIO, M., PORTINCASA, P. EFFECTS OF TEMPORARY SACRAL NERVE STIMULATION ON GASTROINTESTINAL MOTILITY AND FUNCTION IN PATIENTS WITH CHRONIC REFRACTORY SLOW-TRANSIT CONSTIPATION. TECH COLOPROCTOL. 2020. DOI: 10.1007/S10151-020-02367-7 SUMMARY: THE EFFICACY OF SACRAL NERVE STIMULATION (SNS) ON PATIENTS WITH CHRONIC REFRACTORY SLOW-TRANSIT CONSTIPATION IS CONTROVERSIAL AND ITS MECHANISM OF ACTION ON GASTROINTESTINAL MOTILITY AND TRANSIT IS NOT FULLY UNDERSTOOD. THE AIM OF THIS STUDY WAS TO DOCUMENT THE EFFECTS OF TEMPORARY SNS ON THE GASTROINTESTINAL AND BILIARY TRACT MOTILITY AND ON GASTROINTESTINAL TRANSIT IN PATIENTS WITH REFRACTORY SLOW-TRANSIT CONSTIPATION. THIS WAS A PROSPECTIVE INTERVENTIONAL STUDY. PATIENTS WITH SLOW-TRANSIT CHRONIC CONSTIPATION, UNRESPONSIVE TO ANY CONSERVATIVE TREATMENT, WERE ENROLLED BETWEEN JANUARY 2013 AND DECEMBER 2018. PATIENTS¿ QUALITY OF LIFE [PATIENT ASSESSMENT OF CONSTIPATION QUALITY OF LIFE (PAC-QOL) QUESTIONNAIRE], CONSTIPATION SCORES (CLEVELAND CLINIC CONSTIPATION SCORE) COLONIC TRANSIT TIME (CTT), OROCECAL TRANSIT TIME (OCTT), GASTRIC AND GALLBLADDER KINETICS, TOGETHER WITH THE ASSESSMENT OF THE AUTONOMIC NERVE FUNCTION WERE EVALUATED BEFORE AND DURING TEMPORARY SNS. RESULTS 14 PATIENTS (12 FEMALES, MEDIAN AGE 38 YEARS, RANGE 24¿42 YEARS) HAD TEMPORARY SNS. THE CLEVELAND CLINIC CONSTIPATION SCORE DID NOT CHANGE COMPARED TO BASELINE (23 ± 3 VS 21.4; P = 070). THE PAC-QOL DID NOT IMPROVE SIGNIFICANTLY DURING THE STIMULATION PERIOD. GALLBLADDER/STOMACH MOTILITY (HALF-EMPTYING TIME) DID NOT CHANGE SIGNIFICANTLY BEFORE AND AFTER SNS. OCTT WAS DELAYED AT BASELINE, AS COMPARED TO STANDARD INTERNAL NORMAL VALUES, AND DID NOT CHANGE DURING SNS. CTT DID NOT IMPROVE SIGNIFICANTLY, ALTHOUGH IN TWO PATIENTS IT DECREASED SUBSTANTIALLY FROM 97 TO 53 H, AND FROM 100 TO 65 H. TEMPORARY SNS DID NOT HAVE ANY EFFECT ON UPPER/LOWER GASTROINTESTINAL MOTILITY AND TRANSIT IN PATIENTS WITH SEVERE CONSTIPATION. REPORTED EVENTS: THREE PATIENTS SHOWING SIGNIFICANT BENEFITS FROM THE ELECTROSTIMULATION UNDERWENT PERMANENT SNS BY AN IMPLANTABLE PULSE GENERATOR. TWO OF THESE PATIENTS HAVE STILL SOME BENEFIT FROM SNS WHILE THE THIRD PATIENT¿S IMPLANT WAS REMOVED BECAUSE OF EARLY POSTOPERATIVE RECURRENCE OF SYMPTOMS. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150370 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention