BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2870718 · Received December 12, 2012

    Report

    Report Number
    3004209178-2012-11763
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Report Date
    November 20, 2012
    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

    PRODUCT ID 3889-28, LOT# V363146, IMPLANTED: (B)(6) 2009, 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 A PATIENT WAS NOT ABLE TO ADJUST STIMULATION. THE REPORTER STATED THAT THE PATIENT INCREASED THE AMPLITUDE 6-7 WEEKS AGO. THE PATIENT MAY HAVE HAD A POWER ON RESET (POR) CONDITION. IT WAS REPORTED THAT THE PATIENT HAD A URODYNAMICS TEST 3 WEEKS AGO. THE REPORTER STATED THAT STIMULATION WAS TURNING OFF. IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT, AND THE PATIENT WAS ALMOST 'MAXED OUT' ON HER THERAPEUTIC PARAMETER. TWO WEEKS LATER, IT WAS REPORTED THAT THE PATIENT STILL HAD CONCERNS WITH HER DEVICE OR THERAPY. THE PATIENT HAD RECEIVED A CALL TO SET UP AN APPOINTMENT. THE REPORTER STATED THAT THE DEVICE NEEDED TO BE RESET. 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
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1