BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2936095 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01152
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 14, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA0199D, IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED NO STIMULATION SENSATION. THREE DAYS PREVIOUS TO THIS REPORT, IT WAS STATED THE PATIENT DID NOT FEEL STIMULATION IN THE MORNING AND HAD AN "ACCIDENT" AFTER GETTING OUT OF BED. ABOUT 15-20 MINUTES AFTER THAT, THE PATIENT COULD FEEL STIMULATION AGAIN. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR HAD BEEN WORKING "GREAT SO FAR" AND THE PATIENT HAD NOT HAD ANY ISSUES UNTIL RECENTLY. STIMULATION WAS INCREASED FROM 1.8 TO 2.0V, BUT THAT DID NOT HELP WITH THE PATIENT'S "MORNING ISSUES." A DIFFERENT PROGRAM WAS SELECTED FOR THE PATIENT TO TRY. NO FALLS OR TRAUMAS WERE REPORTED IN RELATION TO THIS EVENT. IT WAS INDICATED THE PATIENT HAD AN APPOINTMENT WITH THEIR HEALTHCARE PROVIDER ON (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE CAUSE OF THE EVENT WAS UNCLEAR. THE PATIENT WAS DOING WELL WITH THE DEVICE AND DID NOT REPORT ANY ISSUES OF THIS NATURE TO THIS REPORTER. THE PATIENT DENIED PAIN AND HAD 80% IMPROVEMENT IN LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40533 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1