BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 4171631 · Received October 14, 2014

    Report

    Report Number
    3007566237-2014-02987
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 20, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4). PART OF THE DISTAL PORTION OF THE CATHETER AND TWO ANCHORS WERE RETURNED FOR ANALYSIS. THE GUIDEWIRE WAS NOT RETURNED. A HOLE WAS FOUND AT THE 22 CENTIMETER (CM) MARKING ON THE CATHETER. THE CHARACTERISTICS OF THE HOLE WERE VERY TYPICAL OF A SHEAR HOLE CAUSED BY AN INTERACTION OF THE CATHETER WITH ITS GUIDEWIRE DURING THE IMPLANT PROCEDURE. IN CONCLUSION, THE CATHETER BODY DAMAGED OCCURRED TO THE CATHETER BODY AND/OR GUIDEWIRE DURING THE IMPLANT PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN OPENED THE PACKAGE AND WAS READY TO IMPLANT THE CATHETER IN THE OPERATION BUT FOUND THE CATHETER WAS BROKEN. THE SURGERY WAS DELAY FOR APPROXIMATELY ONE HOUR. THE PATIENT WAS CURRENTLY DOING WELL. NO PATIENT SYMPTOMS WERE REPORTED. IT WAS NOT REPORTED WHAT MEDICATION THE DEVICE SYSTEM WAS TO DELIVER. NO ADDITIONAL INFORMATION WAS AVAILABLE. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650061 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 YR