BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3114221 · Received May 15, 2013

    Report

    Report Number
    3004209178-2013-07726
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    April 30, 2013
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# V945725, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ABOUT THREE MONTHS PREVIOUS TO REPORT, IT WAS INDICATED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. A LOSS OF BLADDER CONTROL WAS REPORTED, IN ADDITION TO LEAKING AND FREQUENCY. IT WAS STATED THAT THERAPY WAS WORKING FOR THE FIRST FIVE WEEKS, BUT THEN STOPPED WORKING AFTER A COLON SURGERY. THE PATIENT HAD COLON SURGERY IN (B)(6) 2012. THE PATIENT COULD ALSO NOT FEEL STIMULATION. AS OF THE DATE OF THIS REPORT, IT WAS STATED THE PATIENT HAD A RECTAL PROLAPSE, WHICH WAS THE CAUSE OF THE COLON SURGERY IN (B)(6) 2012. IT WAS UNCLEAR WHEN THE SURGERY OCCURRED AS TWO DIFFERENT DATES WERE REPORTED. IT WAS STATED THE 'DOCTOR SWORE HE NEVER TOUCHED ANYTHING TO DO WITH THE STIMULATION DEVICE. THE THERAPY PRIOR TO THE SURGERY WAS DESCRIBED AS WORKING 'PERFECTLY.' AFTER THE SURGERY, THE PATIENT DEVICE WAS REPROGRAMMED. STIMULATION WAS INCREASED AND THE PATIENT COULD FEEL STIMULATION IN THE BICYCLE SEAT AREA. THE PATIENT CHANGED PROGRAMS AT ONE POINT, BUT HAD TO TURN STIMULATION DOWN BECAUSE IT WAS 'TOO STRONG.' IT WAS ALSO NOTED THE PATIENT WAS UNABLE TO ADJUST STIMULATION AT ONE POINT, BUT WAS ABLE TO AFTER FURTHER TROUBLESHOOTING. IT WAS STATED TO HAVE 'WORKED FOR A WHILE, BUT NOT ANYMORE.' A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214166 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R