BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3162339 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10137
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    June 10, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT # V858935, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3889-28, LOT # V050376, IMPLANTED: (B)(6) 2007, 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

    ABOUT TWO MONTHS PRIOR TO DATE OF THIS REPORT, IT WAS REPORTED THAT INS HAD SLID DOWN INTO BUTT CHECK AND WAS "REALLY HARD WHERE DEVICE WAS." SKIN AROUND DEVICE WAS HARD AND IT WAS UNCOMFORTABLE. THERE WAS "A CRATER UNDERNEATH WHERE THE DEVICE WAS" AND THIS HAD BEEN THERE ABOUT A MONTH. DEVICE SLIDING DOWN STARTED A YEAR AGO AND HAPPENED SLOWLY. THE PATIENT HAD BEEN WORKING OUT THREE DAYS A WEEK, BUT DEVICE STARTED SLIDING DOWN BEFORE THAT. THERAPY WAS STILL HELPING WITH SYMPTOMS. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS ISSUE. TEN DAYS LATER, IT WAS REPORTED THE CAUSE OF THE EVENT WAS BODY FAT LOSS. HOSPITALIZATION WAS NOT REQUIRED. NO PATIENT INJURY. THE PATIENT HAD SIGNIFICANT LOSS OF BODY FAT WITH WORKING OUT AND NOW BATTERY WAS NOT AS DEEP. THE PATIENT WAS SATISFIED. FOUR DAYS LATER, IT WAS STATED THE PATIENT ¿DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY¿ AND THAT THE PATIENT ¿RECEIVED ASSISTANCE FROM THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. IT WAS NOTED THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2013. A LITTLE LESS THAN A MONTH LATER THE PATIENT¿S CONCERNS WERE STILL RESOLVED. THE APPOINTMENT DATE LISTED WAS (B)(6) 2013. IT WAS UNCLEAR WHEN THE PATIENT RECEIVED ASSISTANCE. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262429 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1