BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2190987 · Received July 19, 2011

    Report

    Report Number
    3004209178-2011-05583
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 24, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE STIMULATION WAS INTERMITTENT IN STRENGTH DESPITE TURNING THE STIMULATOR OFF. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR PROGRAMMER: MODEL 3037 LOT# NJD109991N| EXPLANTED:| LEAD: MODEL 3093 LOT# V048775| IMPLANTED: