BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3725332 · Received April 3, 2014

    Report

    Report Number
    3004209178-2014-05613
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Report Date
    March 31, 2014
    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

    PRODUCT ID 3889-28, LOT# V772374, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID NEU_UNKNOWN_PROG, SERIAL# UNKNOWN; PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A GRADUAL RETURN OF SYMPTOMS OVER THE LAST 2 MONTHS. IT WAS STATED THAT SIMULATION NEVER REALLY WORKED AND THE PATIENT HAD NEVER BEEN HAPPY WITH IT. IT WAS NOTED THAT THE PATIENT HAD PROCEDURES FOR MELANOMA AND THOUGHT THE STIMULATION WAS ON. THE PATIENT HAD MORE TREATMENTS COMING UP. THE PATIENT DID NOT FEEL STIMULATION AT THIS TIME. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WOULD TURN STIMULATION OFF BECAUSE, SHE WOULD FEEL A ¿PULLING¿ ON THE LEFT SIDE. THIS WAS STATED TO HAVE STARTED 6 MONTHS AGO. THE PATIENT ADJUSTED STIMULATION AND STILL FELT THE PULLING. IT WAS ALSO MENTIONED THAT THE PATIENT HAD THE SAME ISSUE WITH THE NEW PATIENT PROGRAMMER AS SHE DID WITH HER OLD ONE AND SHE WAS NOT ABLE TO MAKE AN ADJUSTMENT EITHER WITH OR WITHOUT USING THE PATIENT PROGRAMMER ANTENNA. IT WAS NOTED THAT THE PATIENT HAD NO STIMULATION SENSATION. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT HAD NOT SOUGHT FURTHER HELP. IT WAS LATER REPORTED THAT OF THE EVENT WAS UNKNOWN AND HOSPITALIZATION WAS NOT REQUIRED. A HEALTHCARE PROFESSIONAL HAD NOT SEEN PATIENT SINCE 2011 (B)(6) AND AT THAT TIME, THE PATIENT WAS DOING BETTER AND WAS DOING WELL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT THOUGHT THAT THEIR DEVICE WAS NOT WORKING AND NOTED THE TIME FRAME AT ONE YEAR. IT WAS NOTED THAT THE PATIENT DIDN¿T FEEL STIMULATION AND DIDN¿T HAVE THE PATIENT PROGRAMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201501 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR