BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3252402 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12425
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 3, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# V864273, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT AN OVERSTIMULATION SENSATION WHILE STIMULATION WAS TURNED ON. THE REPORTER STATED THAT RECENTLY THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN "STIMULATING MORE" AND WAS ¿GOING HAYWIRE.¿ IT WAS NOTED THAT THIS HAD BEEN HAPPENING FOR A COUPLE OF DAYS. THE PATIENT REPORTEDLY CHECKED THE INS THE NIGHT PRIOR TO THE REPORT AND MOVED IT FROM 2V TO 1V AND THEN TURNED IT OFF, BUT SHE COULD STILL FEEL THE STIMULATION ONE DAY LATER. IT WAS NOTED THAT THE PATIENT HAD NO FALLS OR TRAUMA. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352259 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1