BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3482680 · Received November 21, 2013

    Report

    Report Number
    3004209178-2013-21270
    Event Type
    Injury
    Date Received
    November 21, 2013
    Report Date
    November 8, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V850492, IMPLANTED: 2011-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A REVISION SURGERY ON 2013-(B)(6) TO REPLACE THE IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD. IT WAS STATED THAT THE LEAD HAD SHIFTED AND WHEN STIMULATION WAS TURNED ON IT WOULD STIMULATE AND MOVE HER FOOT. IT WAS NOTED THAT THERE WAS CONSTANT CURRENT RUNNING DOWN THE LEFT LEG AND THE PATIENT'S TOES WOULD CURL. IT WAS NOTED THAT THE STIMULATION WAS NOT PAINFUL, BUT THE PATIENT'S FOOT WOULD BECOME PAINFUL FROM CRAMPING AND MAKING THE TOES CURL. IT WAS FURTHER NOTED THAT IT WOULD MAKE HER BACK MUSCLES TENSE AND PAINFUL AS WELL. THIS ISSUES STARTED ¿ABOUT 9 MONTHS TO A YEAR PRIOR¿ TO THE REPLACEMENT SURGERY.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WERE WORKING WITH THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE AND THEY ALSO STATED THEY HAD NOT SOUGHT FURTHER HELP. THE PATIENT STATED THEY RECEIVED ABSOLUTELY NO ASSISTANCE BECAUSE THEIR DOCTOR RETIRED. THE PATIENT STATED THEY SAW THEIR DOCTOR ONE LAST TIME BEFORE THEY RETIRED BETWEEN (B)(6) 2013 AND AT THAT TIME, IT APPEARED THE SETTINGS OR PROGRAMS WERE WORKING PROPERLY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT STIMULATION WITH THE PATIENT'S PREVIOUS DEVICE WAS GOING DOWN THEIR FOOT AND MADE THEIR TOES MOVE AND THE PROBLEM STARTED ABOUT A YEAR AFTER IT WAS PUT IN. THE PATIENT'S NURSE CHANGED THEIR SETTINGS AND IT WAS A LOT BETTER BUT THEY ONLY HAD 1 SETTING THAT THEY COULD USE WHERE THE SIGNAL DID NOT GO DOWN THEIR FOOT AND IT WAS NOT THE BEST SETTING TO CONTROL THEIR URINARY SYMPTOMS. IT WAS NOTED THAT THE FACT THAT THE PATIENT FELT STIMULATION IN THE WRONG LOCATION WAS THE REASON THEY REPLACED THE SYSTEM IN (B)(6) 2013 AND SWITCHED THE LOCATION FOR THE IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD. THE PREVIOUS INS WAS ON THE PATIENT'S RIGHT SIDE AND THE LEAD WAS ON THEIR LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606026 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Required Intervention