BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4132902 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18098
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 9, 2014
    Report Date
    September 9, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. PRODUCT ID: 3889-28, LOT# V749365, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT WAS HAVING A RETURN OF SYMPTOMS. THE PATIENT NOTED IT HADN'T BEEN WORKING FOR THE PAST SEVERAL MONTHS. THE PATIENT CHANGED THE BATTERIES IN THE BACK OF THE CONTROLLER AND THAT DIDN'T HELP. PATIENT SERVICES ASKED THE PATIENT IF SHE HAD TRIED CHANGING PROGRAMS OR TURNING STIM UP. THE PATIENT STATED: NO. PATIENT SERVICES OFFERED TO CHANGE SETTINGS OVER THE PHONE BUT THE PATIENT DECLINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT WITH LOSS OF BLADDER CONTROL. THE EVENT OR SYMPTOMS OCCURRED DURING THE PAST SEVERAL MONTHS. INTERSTIM HAD NOT BEEN WORKING FOR THE PAST SEVERAL MONTHS. THE PATIENT WAS WETTING ALL THE TIME. THE PATIENT NOTED HER PROGRAMMER WAS NOT WORKING EITHER. THE PATIENT DID NOT REMEMBER WHAT THE PROGRAMMER SAID. THE PATIENT USUALLY DOES NOT FEEL ANY STIMULATION, BUT IT SEEMED LIKE THE INTERSTIM WAS NOT ON OR WORKING. THE PATIENT WAS NOT ABLE TO CONNECT. THE PATIENT WAS UNABLE TO GET A READING FOR THE LAST FEW MONTHS ON THE PATIENT PROGRAMMER. THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. NO STIMULATION SENSATION WAS NOTED. THE PATIENT DID HAVE A FALL A FEW MONTHS AGO IN WHICH SHE FELL FORWARDS. PRIOR TO NOW, SHE LAST CHECKED IMPLANT USING PROGRAMMER ABOUT ONE YEAR AGO. THE PATIENT HADN'T HAD HER DEVICE CHECKED AT HCP (HEALTHCARE PROVIDER) OFFICE IN QUITE A WHILE. 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
    612797 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR