BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPOSABLE CONCENTRIC NEEDLE ELECTRODE

    MDR report key: 2792457 · Received October 8, 2012

    Report

    Report Number
    3004827015-2012-00001
    Event Type
    Other
    Date Received
    October 8, 2012
    Date of Event
    September 5, 2012
    Report Date
    October 5, 2012
    Manufacturer
    ALPINE BIOMED APS
    Product Code
    IKT
    PMA / PMN Number
    K931966
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REMAINING 13 NEEDLES FROM SAME BOX (LOT) WERE TESTED AND ALL EXCEEDED PRODUCT SPECIFICATION REQUIREMENT AND MANUFACTURING TEST REQUIREMENT REGARDING TENSILE TEST WITH GREAT MARGIN. ACTUAL DEVICE NOT RETURNED FOR INVESTIGATION. THE IFU CONTAINS FOLLOWING WARNING: "WHEN INSERTING THE NEEDLE ELECTRODE IN THE PATIENT, IT IS RECOMMENDED THAT IT NOT TO BE INSERTED UP TO THE HUB." THE WARNING IS SPECIFICALLY INSERTED TO AVOID THE NEEDLE SHAFT TO REMAIN UNDER THE SKIN IN THE UNLIKELY EVENT THAT THE NEEDLE BECOMES DISLODGED FROM THE HUB. AS THE DOCTOR DETERMINED IT WAS TOO DIFFICULT TO REMOVE THE REMAINING NEEDLE, IT INDICATES THAT THE NEEDLE WAS NOT ONLY INSERTED UP TO THE HUB, BUT ALSO PRESSED DEEPLY INTO THE SKIN. THIS INDICATES THAT THE PERSON CONDUCTING THE EMG EXAMINATION SHOULD HAVE CHOSEN A LONGER AND THICKER NEEDLE TO AVOID THIS SITUATION WHERE THE NEEDLE IS LEFT DEEP IN THE MUSCLE. WE CONSIDER THIS TO BE AN ISOLATED CASE CAUSED BY UNINTENDED USE OF THE PRODUCT.

    Description of Event or Problem · 1

    THE DOCTOR DID TWO INSERTIONS IN THE PATIENT WITH THE SAME NEEDLE ELECTRODE. THE NEEDLE DISLODGED FROM THE HUB (PLASTIC HEAD) AFTER SECOND INSERTION AND STAYED IN THE PATIENT'S MUSCLE. THE DOCTOR WAS NOT ABLE TO REMOVE THE NEEDLE AND DECIDED TO LEAVE IT IN THE MUSCLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE CONCENTRIC NEEDLE ELECTRODE DIAGNOSTIC EMG NEEDLE ELECTRODE IKT ALPINE BIOMED APS DCN 37 47786

    Patients

    Seq Age Sex Outcome Treatment
    1 Other