BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4081815 · Received September 11, 2014

    Report

    Report Number
    3004209178-2014-16833
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Report Date
    August 18, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3889-28, LOT# V162346, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# V062663, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 3037; SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CALLED IN BECAUSE SHE WAS GETTING AN ERROR MESSAGE ON HER PATIENT PROGRAMMER. THE PATIENT REPORTS A POR (POWER ON RESET) CONDITION. THE PATIENT SAID SHE EITHER GETS A POR MESSAGE OR THE POOR COMMUNICATION SCREEN ON HER PATIENT PROGRAMMER. THE PATIENT SAID SHE HAS TWO IMPLANTS SHE WAS GETTING THE SAME MESSAGES ON BOTH IMPLANTS. IT WAS NOTED THIS STARTED A COUPLE WEEKS AGO. THE PATIENT MENTIONED SHE WASN'T FEELING STIMULATION. THE PATIENT ASKED IF IT HAS ANYTHING TO DO WITH THE AGE OF HER DEVICES. IT WAS MENTIONED THE PATIENT JUST HAD THEM REPLACED IN 2013. THE PATIENT SAID SHE DID NOT HAVE THEM REPLACED IN 2013 SHE SAID SHE STILL HAS THE ORIGINAL STIMULATORS THAT WERE FIRST PUT IN (UNCLEAR WHAT THE PATIENT MEANT BY THE STATEMENT). THE PATIENT SAID HER DEVICES USED TO BE WHERE HER BACK POCKETS WERE BUT THE RIGHT ONE WAS MOVING TOWARDS THE OUTSIDE OF HER HIP AND THE LEFT ONE WAS MOVING OUT. THIS STARTED A COUPLE MONTHS AGO. THE PATIENT SAID THE SKIN FEELS LIKE IT WAS GETTING THIN OR STRETCHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560454 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR