BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3355640 · Received September 18, 2013

    Report

    Report Number
    3004209178-2013-16449
    Event Type
    Malfunction
    Date Received
    September 18, 2013
    Report Date
    August 26, 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
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT # V082173, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF BLADDER CONTROL, WAS LEAKING, AND PEEING DOWN HER LEG. IT WAS NOTED THAT THIS HAD BEEN GOING ON FOR A WHILE NOW. THE PATIENT SAW THE PHYSICIAN LAST AUGUST, WHERE THE DEVICE WAS ¿TWEAKED¿ AND THE PATIENT WAS TOLD THAT SHE HAD UNTIL (B)(6) 2013 LEFT WITH THE DEVICE. THE PATIENT WAS SUPPOSED TO GO BACK TO THE PHYSICIAN, BUT HAD NOT BEEN ABLE TO MAKE IT BECAUSE HER HUSBAND BROKE HIS HIP. THE PATIENT COULD FEEL STIMULATION, BUT IT WAS WEAK AND IT WAS NOT CYCLING. THE PATIENT DID GET A FEW MORE PROGRAMS BACK IN AUGUST, HAD TRIED INCREASING STIMULATION ON ALL OF THEM, BUT WAS NOT HAVING LUCK AND STILL HAD ISSUES WITH THERAPY. IT WAS NOTED THAT THE PATIENT WAS REQUESTING DOCTOR INFORMATION BECAUSE HER PHYSICIAN NO LONGER TAKES HER INSURANCE AND SHE NEEDED TO HAVE THE DEVICE REPLACED. IT WAS LATER REPORTED THE PATIENT HAD TO TRAVEL 1.5 HOURS FROM THEIR HOME MANY TIMES FOR TWEAKING OF THEIR DEVICE. IT WAS STATED THE PATIENT THOUGHT THEIR DEVICE HAD NOT WORKED FROM DAY ONE AS THEY HAD HOPED. IT WAS NOTED THE PATIENT HAD THEIR DEVICE REPLACED A WEEK PRIOR TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471170 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Female