BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4192929 · Received October 22, 2014

    Report

    Report Number
    3004209178-2014-20169
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# VA0G3W3, IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID NEU_PT M_PROG, SERIAL# UNKNOWN; PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS INDICATED THAT PATIENT LOSS THERAPEUTIC EFFECT. IT WAS NOTED THAT WEEKS AFTER IMPLANT THERAPY WORKED PERFECTLY, BUT STARTING 2 WEEKS AGO (AND FOR THE PAST 2 WEEKS).THE PATIENT INDICATED THAT SHE FELT LIKE SHE NEVER HAD THE SURGERY. THE PATIENT STATED SHE WAS "FLOODING OUT" EVERY NIGHT. THERE WAS NO FALL /TRAUMA REPORTED. IT WAS INDICATED THAT PATIENT STIMULATION WAS ON, PROGRAM 1 AT 1.8V AND NEVER USED THE PROGRAMMER (PP) OR MADE ANY CHANGES. THE PATIENT REPORTED SHE WAS NERVOUS TO TELL HER HEALTH CARE PROVIDER (HCP) BECAUSE HE WAS CONCERNED THAT PATIENT WAS GETTING IMPLANT BECAUSE, THE PATIENT THOUGHT IT WORKED NOT BECAUSE MANUFACTURER REPRESENTATIVE THOUGHT IT WORKED. FOLLOW UP INFORMATION RECEIVED ON 2014 (B)(6) REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE THERAPY BUT WAS WORKING WITH THEIR DOCTOR. AN APPOINTMENT OF (B)(6) 2014 WAS NOTED. ADDITIONAL INFORMATION RECEIVED ON 2014 (B)(6) INDICATED THAT PATIENT WAS GETTING 50% OR GREATER SYMPTOM REDUCTION. THE CAUSE OF THE EVENT WAS NOT DETERMINED. IT WAS REPORTED AS UNKNOWN IF SYMPTOM WAS RELATED TO INTERSTIM DEVICE. THE PATIENT EXPERIENCED LOSS OF THERAPEUTIC EFFECT AND WAS NOTED AS SUDDEN. IT WAS NOTED THAT REPROGRAMMING WAS DONE AND AFTER IT STOPPED. IT WAS NOTED AS UNKNOWN IF PATIENT EXPERIENCED LOSS OF STIMULATION. THE OUTCOME WAS REPORTED AS UNKNOWN. IT WAS NOTED THAT PATIENT MISSED HER APPOINTMENT ON (B)(6) 2014. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. A FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673662 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR