BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3222376 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11643
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-33, LOT# V887374, IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4), (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS UNABLE TO ADJUST STIMULATION. A ¿CALL YOUR DOCTOR¿ ICON WAS SEEN WITH AN ERROR CODE OF 505. IT WAS NOTED THE CODE INDICATED THE GROUP LIST WAS DELETED AND THE IMPLANTABLE NEUROSTIMULATOR COULD NOT BE TURNED ON. IT WAS STATED THE PATIENT WANTED TO ¿TWEAK¿ THE SETTING TO HELP WITH SYMPTOM CONTROL AT NIGHT. THE ¿DOCTOR SYMBOL¿ WAS RECEIVED ON 2013-(B)(6). ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324066 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR