BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1926384 · Received November 11, 2010

    Report

    Report Number
    3004209178-2010-09270
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 5, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD IMPEDANCES OF >4000 OHMS ON ALL OF THE BIPOLAR PAIRS ON THE LEAD. THE PATIENT SAW A POOR COMMUNICATION SCREEN ON THE PATIENT PROGRAMMER AND COULD NOT ADJUST THE STIMULATION, WITH OR WITHOUT THE ANTENNA ATTACHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 71 YR EXPLANTED:| LEAD: MODEL 3093, LOT# V345145| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD096439N