BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3179143 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-10614
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    May 30, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28 LOT# V223177, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037 LOT# SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION WAS UNABLE TO BE ADJUSTED. A ¿CALL YOUR DOCTOR¿ ICON WAS SEEN AND A POWER ON RESET (POR) CONDITION WAS NOTED. THIS MESSAGE WAS FIRST NOTICED THE WEEK PRIOR WHEN THE PATIENT NOTICED THEY WERE NOT FEELING STIMULATION AND HAVING LEAKING. A LOSS OF THERAPEUTIC EFFECT WAS NOTED. WHEN TRYING TO INCREASE STIMULATION, THE POR MESSAGE CAME UP. IT WAS INDICATED THE PATIENT HAD NOT HAD ANY MEDICAL PROCEDURES THAT COULD HAVE CAUSED THE POR. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS DUE FOR A BATTERY CHANGE AS WELL AS MOVING THE BATTERY SITE BECAUSE IT WAS BOTHERING THEM. THE PROCEDURE WAS CANCELLED THE DAY OF ¿BECAUSE THE REPRESENTATIVE WAS UNABLE TO MAKE IT.¿ THE PATIENT WAS SHAKING AND DEHYDRATED AND THEY GAVE THEM INTRAVENOUS FLUIDS. IT WAS LATER REPORTED THE REPRESENTATIVE WAS UNABLE TO MAKE IT DO TO ¿THINGS BEYOND THEIR CONTROL.¿ ULTIMATELY THE DECISION TO CANCEL THE PROCEDURE WAS MADE BY THE PHYSICIAN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS GETTING PAIN FROM THE POCKET AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280364 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00092 YR