BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3982293 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13999
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# VA0K9H8, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. INABILITY TO ADJUST STIMULATION MAY BE DUE TO POCKET SWELLING AND HEALING AFTER IMPLANT. THE PATIENT WAS IMPLANTED TODAY. THEY TRIED PEELING BANDAGE BACK WHILE USING THE PATIENT PROGRAMMER BUT WERE STILL NOT SUCCESSFUL. THEY WERE SEEING POOR COMMUNICATION SCREEN AS WELL AS A CALL YOUR DOCTOR SCREEN. A POR (POWER ON RESET) CONDITION WAS NOTED. THE HCP (HEALTHCARE PROVIDER) DID NOT TELL THEM THAT USING THE PATIENT PROGRAMMER MAY BE DIFFICULT FOLLOWING IMPLANT. INFORMATION FROM THE HCP NOTED: THE EVENT CAUSE WAS DETERMINED AND IT WAS DEVICE RELATED. REPROGRAMMING WAS NOT NEEDED. THE DEVICE WAS OFF. THEY TURNED THE DEVICE BACK ON AND RESET THE PATIENT'S PROGRAM. THE PATIENT WAS FEELING STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456746 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00033 YR