BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2735873 · Received September 7, 2012

    Report

    Report Number
    3004209178-2012-07907
    Event Type
    Malfunction
    Date Received
    September 7, 2012
    Report Date
    August 10, 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
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT #: V052390, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID: 3037, SERIAL #: (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND HAVING STIMULATION IN THE WRONG LOCATION. THE PATIENT WAS NOT QUITE GETTING THE STIMULATION SHE SHOULD HAVE BEEN GETTING AND THAT SHE EXPERIENCED AN INCREASE IN URGENCY AND FREQUENCY. THE PATIENT'S LAST PROGRAMMING OCCURRED IN (B)(6) 2011. THE PATIENT FELT A LITTLE BIT OF STIMULATION IN THE VAGINAL AREA, BUT ALSO FELT IT "RADIATING DOWN HER KNEES." PROGRAM #3 WAS THE PATIENT'S MOST ACTIVE PROGRAM AT 2.0 VOLTS WITH AN ELECTRODE CONFIGURATION OF 0+, 2-. WITH PROGRAM #3 ACTIVE, THE PATIENT FELT STIMULATION "MORE IN THE BUTTOCK AREA," AND NEEDED IT TO BE "VAGINAL AND [ON THE] TOPS OF THIGHS," AS THIS WAS THE BEST THERAPY FOR HER. IT WAS NOTED THAT DURING AN IMPEDANCE TEST, CONTACT C1 READ "???." IT WAS PLANNED THAT THE CLINICIAN WOULD ATTEMPT TO REPROGRAM THE PATIENT'S THERAPY. 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