BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4092348 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17076
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT # VA0L5JX, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED FLUTTERING IN THEIR WHOLE HIP WHICH WAS NOTED AS MORE THAN THE PATIENT GOT DURING THE PRE-TESTING FOR THE NERVE STIMULATOR. THE PATIENT EXPERIENCED THIS DURING THE OPERATION ON (B)(6) 2014. IT WAS NOTED THAT SOMEONE PUT A CLIP INTO THE PATIENT¿S LEG THAT FELT LIKE A HUGE INJECTION. THE PATIENT EXPERIENCED TWO PAINFUL SHOCKS. THE PATIENT WAS UPSET BECAUSE NO ONE EXPLAIN WHY SHE EXPERIENCED THE PAIN DURING SURGERY AND THE PATIENT NOTED ¿BESIDES BEING NEARLY EXECUTED¿. IT WAS LATER REPORTED THE PATIENT HAD A SHOCKING OR JOLTING SENSATION AND IT WAS NOTED THAT THE SHOCKING HAS HAPPENED INTERMITTENTLY SINCE IMPLANT. THE PATIENT WANTED TO ASK ABOUT SHOCKING. IT WAS NOTED THAT THE PATIENT STIMULATION WAS INCREASED AT HEALTHCARE PROVIDER OFFICE VISIT AND THE PATIENT WAS STILL FEELING A SMALL SHOCKING IN OTHER PARTS OF HER BODY (LEG, SHOULDER AND ETCETERA.) THE PATIENT SAID THE SHOCKING WAS MORE PRONOUNCED SINCE THE AMPLITUDE HAS BEEN INCREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573635 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR