BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3903125 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12299
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    June 10, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# V481125, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A DAY LATER THAT PATIENT HAD LOST SOME WEIGHT AND THERE WAS MORE MOVEMENT AT THE INS POCKET SITE. THE PATIENT REPORTED NO STIMULATION SENSATION. IT WAS INDICATED THAT THE STIMULATION WAS LAST FELT ABOUT 2 MONTHS AGO AND THAT THE SETTING WAS ON PROGRAM 3 AROUND 3.8V AND SHE WENT TO TRY TO ADJUST SETTINGS ABOUT 3 DAYS AGO AND THAT WAS WHEN SHE NOTICED ISSUE WITH NOT BEING ABLE TO CONNECT. IT WAS REPORTED THAT PATIENT HAD RETURN OF FREQUENCY SYMPTOMS. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380330 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR