BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2665774 · Received July 23, 2012

    Report

    Report Number
    3004209178-2012-05972
    Event Type
    Malfunction
    Date Received
    July 23, 2012
    Report Date
    June 25, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-33, LOT# V142285, IMPLANTED: (B)(6) 2008. 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 NEVER RECEIVING THERAPEUTIC EFFECT. THE PATIENT HAD A LOSS OF BLADDER CONTROL. THE PATIENT'S INCONTINENCE AND URGENCY SEEMED TO BE GETTING WORSE SINCE SHE GOT HER REPLACEMENT. SYMPTOMS BEGAN FOLLOWING THE REPLACEMENT. THE PATIENT REPORTED NO FALLS OR TRAUMA OCCURRING. THE PATIENT INCREASED STIMULATION BUT NOTHING CHANGED. THE PATIENT DID NOT FEEL STIMULATION AT THE TIME. STIMULATION WAS OFF SINCE THE REPLACEMENT. THE PATIENT TURNED ON STIMULATION AND SHE WAS THEN FEELING IT. THE PATIENT FELT STIMULATION IN THE LEFT OF THE VAGINA AND BACK A LITTLE BIT. THE PATIENT WANTED TO FEEL STIMULATION IN THE BIKE SEAT AREA. A WEEK LATER THE PATIENT REPORTED THAT SHE WAS STILL EXPERIENCING TERRIBLE URGENCY AND SOME INCONTINENCE SINCE TURNING THE DEVICE ON. THE PATIENT ADJUSTED PROGRAMS FROM PROGRAM 1 AT 5.6 V TO PROGRAM 2 AT 4.2 V AND WAS GOING TO MONITOR HER SYMPTOMS GOING FORWARD. 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 HAD DIFFICULTY COMMUNICATING WITH THE INS BECAUSE THE PROGRAMMER SCREEN WENT BLANK. AFTER ADDITIONAL EDUCATION THE PATIENT WAS ABLE TO COMMUNICATE WITH THE INS, AND CHANGED TO PROGRAM 1 AT 5.5 V AND PLANNED TO TRACK HER SYMPTOMS. IT WAS NOTED THAT THE INS HAD BEEN TURNED OFF FOR THE FIRST SIX MONTHS AFTER IMPLANT.

    Description of Event or Problem · 1

    FOLLOW UP REPORTED, THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT THEY WERE WORKING WITH THEIR DOCTOR OR MEDTRONIC REPRESENTATIVE. IT WAS STATED "THE HEALTH CARE PROFESSIONAL DID NOT HAVE MUCH KNOWLEDGE OF WORKING WITH THE IMPLANT." NO FURTHER INFORMATION WAS REPORTED.

    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