BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 7871494 · Received September 12, 2018

    Report

    Report Number
    3007566237-2018-02736
    Event Type
    Injury
    Date Received
    September 12, 2018
    Date of Event
    October 3, 2017
    Report Date
    September 12, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: KOMESU YM, AMUNDSEN CL, RICHTER HE, ERICKSON SW, ACKENBOM MF, ANDY UU, SUNG VW, ALBO M, GREGORY T, PARAISO MF, WALLACE D. REFRACTORY URGENCY URINARY INCONTINENCE TREATMENT IN WOMEN: IMPACT OF AGE ON OUTCOMES AND COMPLICATIONS. AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY. 2018; 218 (1): 111 E111-111 E119. DOI: 10.1016/J.AJOG.2017.10.006. PLEASE NOTE THIS DATE IS BASED OFF OF THE ARTICLE¿S ACCEPTANCE DATE AS THE SPECIFIC EVENT DATE WAS NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENTS WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHORS OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: ASKU , UDI#: ASKU. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    LITERATURE ABSTRACT: THE AUTHORS COMPARED TREATMENT EFFICACY AND ADVERSE EVENTS (AES) IN WOMEN (B)(6) YEARS OLD TREATED WITH ONABOTULINUMTOXINA OR SACRAL NEUROMODULATION (SNM). IT WAS FOUND THAT YOUNGER WOMEN EXPERIENCED GREATER ABSOLUTE CONTINENCE, SYMPTOM IMPROVEMENT, AND FEWER URINARY TRACT INFECTIONS (UTIS); BOTH OLDER AND YOUNGER WOMEN HAD BENEFICIAL URGENCY URINARY INCONTINENCE EPISODES (UUIE) REDUCTION, SIMILAR RATES OF OTHER TREATMENT ADVERSE EVENTS AND IMPROVED QUALITY OF LIFE. REPORTED EVENTS: 1.22 WOMEN EXPERIENCED A URINARY TRACT INFECTION (UTI) WHILE USING A SACRAL NEUROMODULATION (SNM) DEVICE. IT WAS NOTED THAT TEN WOMEN WERE (B)(6) YEARS OLD AND THAT 12 WERE (B)(6) YEARS OLD. THE UTI WAS CONSIDERED A TREATMENT-RELATED ADVERSE EVENT. 2.8 WOMEN EXPERIENCED A RECURRENT UTI WHILE USING A SNM DEVICE. IT WAS NOTED THAT TWO WOMEN WERE (B)(6) YEARS OLD AND THAT SIX WERE (B)(6) YEARS OLD. THE UTI WAS CONSIDERED A TREATMENT-RELATED ADVERSE EVENT. 3.6 WOMEN REQUIRED REVISION OR REMOVAL OF THEIR SNM DEVICE. IT WAS NOTED THAT TWO WOMEN WERE (B)(6) YEARS OLD AND THAT FOUR WERE (B)(6) YEARS OLD. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712128 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention