BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZW

    MDR report key: 7542595 · Received May 24, 2018

    Report

    Report Number
    3007566237-2018-01558
    Event Type
    Injury
    Date Received
    May 24, 2018
    Date of Event
    May 20, 2018
    Report Date
    May 24, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    (B)(4). INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE(REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FECAL INCONTINENCE AND GASTROINTESTINAL/ PELVIC FLOOR PATIENT REPORTED THAT THEY HAVE BEEN ADMITTED TO THE HOSPITAL SINCE SUNDAY DUE TO EXCRUCIATING PAIN IN HER LOWER BACK AND THAT THE PAIN WAS SO BAD THAT SHE HAD FALLEN ON THE FLOOR AND COULD NOT GET OFF THE FLOOR AND COULD NOT WALK DUE TO THE PAIN. NO FURTHER COMPLICATIONS WERE NOTED OR ANTICIPATED CLIENT HAS A MEDICAL HISTORY OF CANCER THAT HAS SPREAD TO THE TOP OF THEIR COLON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382950 EZW STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization