BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3030290 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04460
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 14, 2013
    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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 889-28, LOT# VA0334L, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BEING 'ZAPPED' BY THEIR IMPLANTABLE NEUROSTIMULATOR (INS). SPECIFICALLY, THIS OCCURRED WHEN THE PATIENT INCREASED THE STIMULATION WITH THE USE OF THE PROGRAMMER ANTENNA OVER THE IMPLANT. IT WAS NOT CLEAR IF THIS OCCURRED WHEN NOT USING THE ANTENNA. THE PATIENT NOTED THAT THEY HAD 'GOOD DAYS AND BAD DAYS.' THE PATIENT WAS GOING TO THE BATHROOM EVERY 1.5 TO 2 HOURS BUT NOW COULD GO 4 TO 5 HOURS WITHOUT THE NEED TO GO. IT WAS ALSO REPORTED THAT THE PATIENT SEEMED TO LACK A BASIC UNDERSTANDING OF THE PROGRAMMER USE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134299 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1