BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2053626 · Received March 1, 2011

    Report

    Report Number
    3007566237-2011-01533
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 21, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    IT WAS REPORTED THAT THE PT WAS UNABLE TO ADJUST STIMULATION AND THE DEVICE WAS IN A POWER ON RESET (POR) CONDITION. THE DISPLAY SHOWED "CALL YOUR DOCTOR". NO ADDITIONAL INFO WAS GIVEN. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC NEUROMODULATION 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| LEAD: MODEL LEAD URO, LOT# UNK| PROGRAMMER: MODEL 3037, LOT# UNK| IMPLANTED: