BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4662766 · Received April 6, 2015

    Report

    Report Number
    3004209178-2015-06031
    Event Type
    Malfunction
    Date Received
    April 6, 2015
    Report Date
    March 16, 2015
    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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT ID: 3093-33, LOT# V073248, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT A BURNING SENSATION AT THE IMPLANT SITE. IT STARTED A COUPLE OF MONTHS AGO AND THE PATIENT HAD BEEN TRYING TO SEE IF IT WOULD RESOLVE. THE PATIENT TURNED STIMULATION OFF ABOUT A MONTH AGO AND SINCE THEN THEY STILL FELT STIMULATION. THE PATIENT CONFIRMED THEY DID TURN STIMULATION OFF BY PUSHING THE THERAPY OFF BUTTON AND THE IMPLANTABLE NEUROSTIMULATOR (INS) ICON ON THE SCREEN SHOWED NO LIGHTNING BOLT. NO OUTCOME OR INTERVENTIONS WERE 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
    224988 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1