BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1872528 · Received October 12, 2010

    Report

    Report Number
    3004209178-2010-07830
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 14, 2010
    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
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT EXPERIENCED A SHOCKING/JOLTING SENSATION FROM HER IMPLANTED DEVICE. IT OCCURRED WHEN TURNING THE DEVICE ON, AND STARTED ABOUT 2.5-3 WEEKS AGO FOLLOWING A FALL. DETAILS OF THE FALL ARE UNK. IT WAS REPORTED THAT PT RECENTLY HAD BACK SURGERY, AND COULD NOT ALIGN THE PT PROGRAMMER ANTENNA OVER THE IMPLANTED DEVICE DUE TO PHYSICAL LIMITATIONS. THE PT'S OUTCOME WAS NOT REPORTED. ADD'L INFO IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A F/U REPORT AS IT BECOMES AVAILABLE.

    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 53 YR IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD099007N| LEAD: MODEL 3093, LOT# V383049