BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3473058 · Received November 15, 2013

    Report

    Report Number
    3004209178-2013-20940
    Event Type
    Malfunction
    Date Received
    November 15, 2013
    Date of Event
    October 30, 2013
    Report Date
    October 30, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V872659, IMPLANTED: 2012 (B)(6); 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 RECEIVED STIMULATION ADJUSTMENT ASSISTANCE EITHER ON THE PREVIOUS NIGHT OR TWO DAYS AGO. IT WAS STATED THAT THE PATIENT HAD HIS STIMULATION INCREASED, BUT WAS UNSURE WHEN THAT HAD OCCURRED. THE PATIENT WAS REPORTED AS FEELING STIMULATION ¿TOO HIGH¿ ON THE DAY OF THIS REPORT AND HAD WANTED IT DECREASED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS FEELING STIMULATION THAT WAS HURTING HIS BUTTOCKS. THE PAIN WAS NOTED AS HAVING STARTED ON THE NIGHT PRIOR TO THIS REPORT AND WAS REPORTED AS ¿KILLING¿ THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593350 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR