BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2704098 · Received August 17, 2012

    Report

    Report Number
    3004209178-2012-07008
    Event Type
    Malfunction
    Date Received
    August 17, 2012
    Report Date
    July 19, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-33, LOT# V801866, IMPLANTED: (B)(6) 2011. 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 WAS NOT ABLE TO ADJUST STIMULATION AND WAS UNABLE TO TURN THE STIMULATION OFF. IT WAS NOTED THAT THE PATIENT WAS USING PROGRAM 3 AT 0.5 VOLTS AND EXPERIENCED A WHIPLASH SENSATION IN THE PERINEUM AREA OF THE BODY. THE PATIENT STATED THAT SHE HAD BEEN EXPERIENCING THIS SENSATION FOR ABOUT A WEEK AND IT WAS "GREATLY AFFECTING HER LIFE." THE PATIENT STATED THAT "IT HAD BEEN FAILING FOR 2 WEEKS." IT WAS NOTED THAT INITIALLY THE PATIENT WAS NOT USING THE ANTENNA AND WAS OCCASIONALLY SEEING THE "POOR COMMUNICATION" SCREEN ON THE PATIENT PROGRAMMER. THE PATIENT WAS "CONFIDENT THAT SHE WAS USING IT CORRECTLY." BASIC FUNCTIONALITY OF THE DEVICE WAS REVIEWED. THE PATIENT STATED THAT THE "MIDDLE KEY LOOKED DEPRESSED" AND NOTICED NO CHANGE AFTER DEPRESSED ALL THE KEYS ONE AT A TIME. THE PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1