BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3420577 · Received October 21, 2013

    Report

    Report Number
    3004209178-2013-19394
    Event Type
    Malfunction
    Date Received
    October 21, 2013
    Report Date
    September 27, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-33, LOT# V833270, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S SYMPTOMS STARTED TO RETURN AND THEY FELT NO STIMULATION ABOUT THREE WEEKS PRIOR. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT COMMUNICATING WITH THE PATIENT PROGRAMMER. THE PATIENT WENT TO THE DOCTOR¿S OFFICE TWO DAYS PRIOR AND THEY COULD NOT COMMUNICATE WITH THE INS EITHER. IT WAS NOTED THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2013. 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
    539619 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1