BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2241036 · Received August 17, 2011

    Report

    Report Number
    3004209178-2011-06494
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 26, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IMPEDANCES >4,000 OHMS WERE REPORTED ON SOME BIPOLAR PAIRS. IT WAS NOTED THAT ONE BIPOLAR PAIR "WAS WORKING". RE-RUNNING THE IMPEDANCE TEST AT DEFAULT VALUES DID NOT RESOLVE THE ISSUE. NO OTHER TESTS WERE PERFORMED TO DETERMINED THE CAUSE OF THE HIGH IMPEDANCES, AND NO INTERVENTIONS WERE PLANNED. THERE WERE NO PT SYMPTOMS ASSOCIATED WITH THIS EVENT. THE PT WAS DOING WELL. FURTHER ACTION WAS NOT GOING TO TAKE PLACE UNTIL FURTHER NOTIFICATION FROM THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR EXPLANTED:| LEAD: MODEL 3093, LOT# V171374| PROGRAMMER: MODEL 3037, LOT# NJD072877N| IMPLANTED: