BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3871879 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-11545
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    May 24, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# VA0HH5U, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID NEU_UN KNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR HEALTH CARE PROVIDER (HCP) OR MANUFACTURER REPRESENTATIVE. IT WAS ALSO REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT HAD NOT SOUGHT FURTHER HELP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT SAT AND MOVED ON THE COUCH THEIR IMPLANTABLE NEUROSTIMULATOR (INS) MOVED. THE PATIENT THEN TRIED TO REPOSITION IT BACK AND AS A RESULT THEY DID NOT FEEL THE STIMULATION. THE PATIENT WAS THEN ABLE TO SYNCHRONIZE THE PROGRAMMER UNIT WITH THE INS WHERE IT SHOWED THAT THEY WERE ON PROGRAM 2 AT 3.20 AND THAT THE STIMULATION WAS OFF. THE PATIENT WAS ABLE TO FEEL THE STIMULATION ONCE THE THERAPY WAS TURNED BACK ON. THE PATIENT STATED THAT THE STIMULATION WAS THE SAME AS BEFORE, IN THEIR BACK AND BOTTOM. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349978 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR