BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3298895 · Received August 20, 2013

    Report

    Report Number
    3004209178-2013-14885
    Event Type
    Malfunction
    Date Received
    August 20, 2013
    Report Date
    August 2, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL#(B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT# V841549, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ABOUT NINE MONTHS PRIOR TO THE DATE OF THIS REPORT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT WAS GETTING GOOD BENEFIT FOR ¿A WHILE,¿ BUT FOR THE PRIOR MONTH ¿OR SO¿ THE PATIENT EXPERIENCED AN INCREASED SYMPTOMS. IT WAS FURTHER NOTED THE PATIENT DID NOT RECEIVE ADEQUATE TRAINING ON USING THE PROGRAMMER. IT WAS ADDED THE PATIENT PROGRAMMER WAS ¿DEAD,¿ BUT THE ISSUE WAS RESOLVED WITH TROUBLESHOOTING. DURING TROUBLESHOOTING, THE AMPLITUDE WAS INCREASED TO 2.5V AND THE PATIENT FELT STIMULATION IN THE CORRECT LOCATION. AS OF THE DATE OF THE REPORT IT WAS STATED THAT ¿IT WAS NOT WORKING¿ AND THE PATIENT DID NOT KNOW WHAT THE PROBLEM WAS. IT WAS INDICATED THAT THE IMPLANTABLE NEUROSTIMULATOR HAD NOT BEEN WORKING FOR ABOUT THE LAST YEAR, BUT IT WAS UNCLEAR FOR EXACTLY HOW LONG. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT EXPERIENCED NO STIMULATION SENSATION. THE PROGRAMMER RESUMED FUNCTION AFTER THE BATTERIES WERE CHANGED. IT WAS STATED THE PATIENT NEEDED ASSISTANCE IN CHANGING PROGRAMS; HOWEVER, THEY ONLY HAD ACCESS TO ONE PROGRAM. THE PATIENT HAD NOT USED OTHER PROGRAMS BEFORE. EVENTUALLY, THE PATIENT WAS ABLE TO INCREASE STIMULATION FROM 3.5V TO 3.9V ON PROGRAM 1 AND COULD FEEL STIMULATION COMFORTABLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401859 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR