BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3241469 · Received July 22, 2013

    Report

    Report Number
    3007566237-2013-02436
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3057-1SC, LOT# N368885, PRODUCT TYPE SCREENING DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ALLERGIC REACTION TO LIDOCAINE DURING THE USE OF A FORAMEN NEEDLE TO ACCESS THE FORAMEN. IT WAS NOTED THAT LIDOCAINE WAS INJECTED AT THE SACRAL AREA AND THE PATIENT BECAME INCOHERENT AND THEIR BLOOD PRESSURE DROPPED. IT WAS NOTED THAT NO LEADS WERE PLACED IN THE PATIENT. IT WAS FURTHER NOTED THAT THE CASE WAS ABORTED AND THE PATIENT WAS TAKEN TO THE HOSPITAL. IT WAS FURTHER NOTED THAT THE PATIENT WAS RELEASED FROM THE HOSPITAL TWO DAYS LATER AND WAS DOING WELL. IT WAS NOTED THAT THE CAUSED WAS DETERMINED TO BE A REACTION TO LIDOCAINE UNRELATED TO THE PRODUCT. IT WAS NOTED THAT AT THE TIME OF THE REPORT THE PATIENT WAS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341376 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3065USC N375405

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization