BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 6187257 · Received December 19, 2016

    Report

    Report Number
    2647346-2016-00033
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Report Date
    December 19, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A CONSUMER WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION. THE HCP REPORTED THAT THE DEVICE WAS NOT WORKING BUT DID NOT HAVE ANY INFORMATION BEYOND THIS. THE HCP STATED THAT THEY WERE CONFUSED BY GUIDELINES. THE HCP NOTED THAT THE PATIENT HAD A LOW SERIAL NUMBER THAT WAS LESS THAN THE SERIAL NUMBER CALLED OUT IN THE GUIDELINES FOR NO MRI ELIGIBILITY. THE HCP WASN¿T SURE THEY WERE READING IT CORRECTLY. THERE WERE NO PATIENT SYMPTOMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836596 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO, MED REL 3023

    Patients

    Seq Age Sex Outcome Treatment
    1