BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3363395 · Received September 23, 2013

    Report

    Report Number
    3004209178-2013-16773
    Event Type
    Malfunction
    Date Received
    September 23, 2013
    Report Date
    August 30, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT# V062829, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS NOT WORKING. IT WAS STATED TO HAVE STOPPED WORKING IN (B)(6) 2013. THE PATIENT ALSO HAD A RETURN OF SYMPTOMS A COUPLE MONTHS PRIOR, WHICH CORRESPONDED WITH THE DEVICE NOT WORKING. IT WAS NOTED THE PATIENT HAD AN APPOINTMENT IN (B)(6) 2013 TO HAVE THE DEVICE CHECKED. 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
    478967 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR