BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1032789 · Received April 23, 2008

    Report

    Report Number
    3004209178-2008-02142
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 1, 2007
    Report Date
    August 3, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FILE IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED SEIZURES AND SHORTLY AFTER RECEIVING IMPLANT THE PAIN IN HER ABDOMINAL AREA WOULD NOT SUBSIDE AND THEN SHE STARTED EXPERIENCING SHOCKING/JOLTING DOWN LEGS AND PELVIC AREA. IN 2008: THE PT TURNED THE DEVICE OFF WHEN ADMITTED TO HOSPITAL AND STILL EXPERIENCED THE JOLTING.

    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 Required Intervention IMPLANTED| LEAD MODEL 3093 LOT #V016630| EXPLANTED