BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3902600 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12274
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    June 9, 2014
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# VA0AX23, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT STATED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) HAD MOVED AND THEY NOTICED THERAPY CHANGES ABOUT THREE WEEKS PRIOR TO REPORT. IT WAS NOTED THE PATIENT STARTED PHYSICAL THERAPY AT THAT TIME AND THEY WERE DOING ABDOMINAL CRUNCHES. IT WAS STATED THAT RIGHT AFTER IMPLANT THE PATIENT COULD NOT FIND THE DEVICE BUT AT THE TIME OF REPORT THEY COULD FEEL DETAIL ON THE DEVICE. REPORTEDLY, WHEN THE PATIENT GOT UP IN THE MORNING THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WAS STICKING OUT AND WAS CLOSE TO THE SURFACE. IT WAS STATED THE PATIENT HAD A CT SCAN DONE ABOUT A MONTH PRIOR TO REPORT AND THE DEVICE AND LEADS APPEARED FINE IN THE SCAN. IT WAS NOTED THE PATIENT HAD A DOCTOR¿S APPOINTMENT SCHEDULED FOR THE DAY AFTER REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE HEALTHCARE PROVIDER STATED, THE PATIENT DID NOT HAVE A 50 PERCENT OR GREATER SYMPTOM REDUCTION. IT WAS STATED, THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS INVOLVED IN THE EVENT. REPORTEDLY, THE PATIENT THOUGHT THE INS MOVED BUT THE DOCTOR EXAMINED THE PATIENT AND FOUND ITS POSITION WAS CORRECT. IT WAS NOTED REPROGRAMMING WAS DONE AND THE PATIENT¿S DEVICE WAS SWITCHED TO A NEW PROGRAMMING. IT WAS STATED THE EVENT CAUSE WAS NOT DETERMINED AND IT WAS NOT DEVICE RELATED. REPORTEDLY, THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380950 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR