BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2645466 · Received July 9, 2012

    Report

    Report Number
    3004209178-2012-05332
    Event Type
    Malfunction
    Date Received
    July 9, 2012
    Report Date
    June 15, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# V914059, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2012 THAT THE PATIENT WAS NEVER RECEIVING A THERAPEUTIC EFFECT. THE PATIENT'S SYMPTOMS WERE LOSS OF BLADDER CONTROL, WHICH OCCURRED FOLLOWING THE IMPLANT. THE PATIENT'S SYMPTOMS WERE GRADUALLY GETTING WORSE. THE PATIENT STATED THAT SHE DOES NOT FEEL STIMULATION, HOWEVER, SHE CONFIRMED THAT STIMULATION IS ON WITH HER PROGRAMMER. ON (B)(6) 2012, IT WAS REPORTED THAT THE PATIENT INCREASED STIMULATION .1 OR .2 DAILY FOR POSSIBLY WEEKS OR MONTHS, AND WAS AT A MAXIMUM STIMULATION LEVEL BETWEEN 8 AND 9. THE PATIENT COULD FEEL STIMULATION, BUT IT WOULD COME AND GO. THE PATIENT'S SYMPTOMS HAD NOT RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT FEEL THAT THE DEVICE HELPED HER. IT WAS NOTED THAT NO HOSPITALIZATION WAS REQUIRED AND THAT NO EVENT HAD OCCURRED.

    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