BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1203215 · Received October 17, 2008

    Report

    Report Number
    3004209178-2008-06682
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 17, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEW WEEKS FOLLOWING IMPLANT THE PATIENT EXPERIENCED A BURNING AND SHOCKING SENSATION. THE PATIENT COULD NOT DISTINGUISH THE EXACT LOCATION OF THE SHOCKING. THE IMPLANT SITE WAS HEALING BUT STILL SWOLLEN. THE SENSATION WENT AWAY WHEN THE DEVICE WAS TURNED DOWN AND OFF AND RETURNED WHEN THE DEVICE WAS TURNED BACK ON. FURTHER INFORMATION IS BEING REQUESTED FROM THE HCP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention IMPLANTED:| LEAD: MODEL 3093| PROGRAMMER: MODEL| EXPLANTED: