BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2061809 · Received March 30, 2011

    Report

    Report Number
    3007566237-2011-02407
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 17, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    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

    IT WAS REPORTED THAT THE PATIENT HAD IMPEDANCE MEASUREMENTS OF >4000 OHMS ON ALL BIPOLAR AND UNIPOLAR ELECTRODE PAIRS. IT WAS ALSO NOTED THAT THE PATIENT FELT THE STIMULATION DURING THE IMPEDANCE TESTING. THE PATIENT OUTCOME WAS REPORTED AS SHE WAS "DOING GREAT" AND "LOVED" THE DEVICE AND DID NOT WANT TO MAKE ANY FURTHER CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC NEUROMODULATION 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1