BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 4190402 · Received October 21, 2014

    Report

    Report Number
    3004209178-2014-20113
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Report Date
    October 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# VA0JQ5M, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WANTED TO KNOW WHY THEIR IMPLANT WAS NOT HOLDING. THE PATIENT PUT IT ON THE SURFACE OF THE INCISION AND THEY DIDN¿T FEEL AND FELT THE TINGLING SENSATION. THE PATIENT WANTED TO KNOW HOW LONG THEY WERE SUPPOSED TO LEAVE IT THERE. THE PATIENT¿S THERAPY WORKED IN THE BEGINNING FOR THE FIRST WEEK TO 2 WEEKS BUT SINCE THEN THEY WERE STILL WETTING THEMSELF, STILL WET THE BED, AND WAS STILL WETTING THEMSELF WHEN THEY WENT TO THE BATHROOM. THE PATIENT DID NOT FEEL STIMULATION IN THE BICYCLE SEAT AREA AND HAD BEEN TRYING TO USE THEIR PATIENT PROGRAMMER AND THEY FELT STIMULATION BUT IT DIDN¿T LAST. THE PATIENT FELL 2 DAYS AGO BUT IT WASN¿T WORKING BEFORE AND THEY WERE PEEING ALL OVER THE PLACE BEFORE THEY FELL. THE DIRECTION THE PATIENT¿S HEALTH CARE PROVIDER (HCP) GAVE THEM ABOUT MAKING CHANGES TO THEIR STIMULATION WAS TO PUT IT ON THE SKIN AND PRESS THE PLUS TO GET STIMULATION. THE PATIENT SAW THE LIGHTNING BOLT AND A 2 AND A 6.0 ON THEIR PROGRAMMER AND THEY SAW A 6 ALL THE TIME AND IT WAS NOT WORKING AND THEY WANTED TO KNOW HOW TO INCREASE IT. THE PATIENT TRIED TO PUSH THE PLUS BUTTON AND GOT THE UPPER LIMIT REACHED SCREEN. THEY TRIED TO PUSH THE MINUS BUTTON 1 TIME AND THE PATIENT COULD NOT CAUSE ANY CHANGES AND THE NUMBER WAS STILL 7. THE PATIENT WAS UNABLE TO USE THE PROGRAMMER TO MAKE CHANGES TO THEIR STIMULATION AND THEY WERE HOME ALONE AND HAD NO ONE TO HELP THEM. THE PATIENT HAD AN APPOINTMENT IN 7 DAYS. IT WAS LATER REPORTED THAT IT WAS UNKNOWN IF THERE WAS A 50 PERCENT OR GREATER SYMPTOM REDUCTION. THE CAUSE OF THE EVENT WAS DETERMINED AND IT WAS DEVICE RELATED. REPROGRAMMING WAS NEEDED AND THE AMPLITUDE WAS INCREASED FROM 6.0V TO 9.4V WHERE THEY WERE ABLE TO FEEL IT ON (B)(6) 2014. THE PATIENT EXPERIENCED A SUDDEN LOSS OF THERAPEUTIC EFFECT AND A SUDDEN LOSS OF STIMULATION. IT WAS UNKNOWN HOW THE PATIENT WAS DOING NOW. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667703 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3023

    Patients

    Seq Age Sex Outcome Treatment
    1