BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3781599 · Received April 30, 2014

    Report

    Report Number
    3004209178-2014-08258
    Event Type
    Injury
    Date Received
    April 30, 2014
    Report Date
    April 11, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA0AZZC, IMPLANTED: 2014-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS RECENTLY IMPLANTED, (B)(6) 2014. THE PATIENT NOTED: "PEOPLE KEEP ASKING ME EXACTLY WHAT THIS STIMULATOR DOES, SO I'D LIKE TO TALK TO SOMEONE WHO CAN TELL ME WHAT IT DOES." THE PATIENT NOTED THEY HAD URGENCY (CANNOT MAKE IT TO THE BATHROOM IN TIME), FREQUENCY AND LEAKING. THE PATIENT ASKED IF THE IMPLANTABLE NEUROSTIMULATOR (INS) WILL HELP WITH THEIR LEAKING. THE PATIENT STATED: "WHEN I DON'T GO TO THE BATHROOM WHEN I FEEL THAT, THEN I LEAK." REGARDING HOW THE THERAPY WAS WORKING, THE PATIENT NOTED THEY HAD TO TURN THE INS OFF BECAUSE "I HAD AN ATTACK OF VERTIGO AND WAS IN THE HOSPITAL. IT WAS OK BEFORE THAT." THE PATIENT WAS TO SEE THE DOCTOR YESTERDAY, BUT HAD TO RESCHEDULE TO (B)(6) 2014 DUE TO THE VERTIGO. THE PATIENT ASKED FOR FIELD REPRESENTATIVE. THE PATIENT HAD THEIR FOLLOW UP APPOINTMENT WITH THEIR DOCTOR SCHEDULED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260098 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization