BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 11396640 · Received March 1, 2021

    Report

    Report Number
    2182207-2021-00337
    Event Type
    Injury
    Date Received
    March 1, 2021
    Date of Event
    November 23, 2020
    Report Date
    March 1, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, 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. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, 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

    ARKAWAZI, B. M. F., KAMBER, H. M., ABDULWADOUD, H. N. SHORT- AND LONG-TERM EFFECTIVENESS OF SACRAL NERVE STIMULATION IN PATIENTS WITH OVERACTIVE BLADDER. OPEN ACCESS MACEDONIAN JOURNAL OF MEDICAL SCIENCES. 2020. 8(B):1207-1211. DOI: 10.3889/OAMJMS.2020.5433 SUMMARY: SACRAL NERVE STIMULATION (SNS) APPROVED FOR USE IN NORTH AMERICA SINCE 1997 DESPITE THE FACT THAT THE CONCEPT OF USING SNS TO TREAT PATIENTS WITH VOIDING DYSFUNCTION DISCUSSED FIRST ALMOST 50 YEARS AGO. THE OBJECTIVES OF THE STUDY WERE TO ASSESS THE EFFECTIVENESS OF SNS THE SHORT AND LONG TERM FOR PATIENTS WITH OVERACTIVE BLADDER (OAB) DYSFUNCTION AND ITS RELATION TO AGE, GENDER, AND CAUSES. THIS IS A CLINICAL PROSPECTIVE STUDY THAT INVOLVED 50 CASES (32 FEMALES AND 18 MALES) WITH OAB. IT WAS CARRIED OUT AT IBN SINA HOSPITAL, AND THE NEUROSCIENCES HOSPITAL IN BAGHDAD/IRAQ FROM APRIL 2015 TO APRIL 2018. ALL THE PATIENTS WERE ASSESSED PREOPERATIVELY AND CERTAIN INCLUSION CRITERIA WERE USED. THE PATIENTS WENT THROUGH THE 2 STAGE IMPLANTATIONS OF THE MEDTRONIC INTERSTIM®. THE PATIENTS WERE ASSESSED AT 6 MONTHS (SHORT TERM) AND 2 YEARS (LONG TERM) POSTOPERATIVELY. THE RESULTS OF OUR PATIENTS WERE ANALYZED WITH RESPECT TO AGE, GENDER, CAUSES OF OAB, AND POST-OPERATIVE COMPLICATIONS. WE FOUND THAT YOUNGER AGE PATIENTS, FEMALE PATIENTS, AND PATIENTS WITH NEUROGENIC CAUSES OF OAB SHOWED A BETTER RESPONSE IN BOTH THE SHORT- AND LONG-TERM FOLLOW-UP. CONSIDERABLE PROGRE SS HAS BEEN MADE IN THE SURGICAL MANAGEMENT OF OAB. PROPER SELECTION OF PATIENTS IS THE KEY TO THE SUCCESS OF SNS, AND FEMALE PATIENTS HAVE BETTER RESULTS COMPARED TO MALE PATIENTS. FURTHERMORE, YOUNGER PATIENTS AND PATIENTS WITH NEUROGENIC CAUSES DID BETTER THAN OLDER PATIENTS AND PATIENTS WITH IDIOPATHIC CAUSES. SNS IS A SAFE MINIMALLY INVASIVE SURGERY WITH A LOW COMPLICATION RATE, AND THE 2 STAGES PROCEDURE HAS BETTER RESULTS THAN THE PERCUTANEOUS NERVE EVALUATION. REPORTED EVENTS: 1. 4 PATIENTS EXPERIENCED AN INFECTION. THE INFECTIONS WERE TREATED WITH METICULOUS DRESSING AND ANTIBIOTICS. 2. ON PATIENT EXPERIENCED AN ELECTRODE MOVEMENT. THE ELECTRODE MOVEMENT WAS TREATED BY SURGICAL REPOSITIONING OF THE ELECTRODE. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292637 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other