BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4051516 · Received September 2, 2014

    Report

    Report Number
    3004209178-2014-16226
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    July 25, 2014
    Report Date
    August 7, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3 093-28, LOT# VA0EM0X, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO STIMULATION SENSATION AND HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT THOUGHT THEY WERE HAVING TROUBLE WITH THEIR DEVICE SO THEY CALLED THEIR HEALTH CARE PROVIDER¿S (HCP¿S) OFFICE AND SPOKE TO THE NURSE WHO REDIRECTED THEM TO THEIR MANUFACTURER REPRESENTATIVE AND THEY DIDN¿T HAVE THEIR CONTACT INFORMATION. IT WAS NOTED THAT THE PATIENT HAD A BLADDER INFECTION 13 DAYS AGO AND 6 DAYS AGO IT HAD BEEN A WEEK. THE PATIENT WAS PROVIDED ANTIBIOTICS BUT EVER SINCE THE BLADDER INFECTION THEY HAD TO URINATE EVERY 10 MINUTES OR SO AND SOMETHING DIDN¿T FEEL RIGHT. IT WAS STATED THAT THE PATIENT MENTIONED ALL OF THIS TO THE HCP¿S OFFICE BUT THEY STILL REDIRECTED THEM TO THE MANUFACTURER REPRESENTATIVE. THE PATIENT WAS NOT CURRENTLY FEELING STIMULATION AND THEY TURNED THEIR DEVICE OFF FOR A FEW HOURS AND THEN TURNED IT BACK ON TO SEE IF THAT WOULD HELP. IT WAS REPORTED THAT WHEN THE PATIENT TURNED IT BACK ON THEY INCREASED STIMULATION TO THE HIGHEST SETTING THEY HAD PROGRAMMED BUT STILL COULDN¿T FEEL STIMULATION. THIS WAS THE PATIENT¿S THIRD DEVICE SO THEY WERE WELL VERSED ON HOW TO USE THEIR DEVICE AND PROGRAMMER AND KNEW WHEN SOMETHING WASN¿T RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534810 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention