BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2251088 · Received September 8, 2011

    Report

    Report Number
    3004209178-2011-07587
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Report Date
    August 31, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    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 A LOSS OF EFFECT AND DIFFERENCE IN STIMULATION FOLLOWING A FALL. THE PATIENT ALSO HAD AN OVERSTIMULATION SENSATION. THE PATIENT MET WITH A COMPANY REPRESENTATIVE. THE DEVICE WAS INTERROGATED AND ALL WAS FUNCTIONING PROPERLY. IT WAS NOTED THAT "ALL WAS WELL."

    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 LEAD: MODEL 3093, LOT# V593423| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD119589N| IMPLANTED:| EXPLANTED:| EXPLANTED: