BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION PUMP

    MDR report key: 2914149 · Received January 14, 2013

    Report

    Report Number
    3007566237-2013-00167
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Report Date
    December 20, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DISTAL PORTION OF THE CATHETER (SERIAL #: (B)(4)) FOUND DAMAGE OCCURRED TO CATHETER BODY AND/OR GUIDEWIRE DU RING IMPLANT PROCEDURE. SIX SEPARATE SEGMENTS WERE RETURNED. ALL THE RETURNED SEGMENTS HAD SIGNIFICANT SHEAR HOLES. OTHER THAN THE PROXIMAL END OF SEGMENT 1, ALL THE OTHER ENDS OF THE SEGMENTS APPEARED TO HAVE BEEN TORN WHICH WERE CONSISTENT WITH SHEARING.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS PERFORATED AT THE CATHETER CONNECTOR SITE. THE CATHETER WAS NOT USED IN THE IMPLANT PROCEDURE. THERE WAS NO PATIENT ISSUE, THERAPY PROBLEM, OR MEDICAL PROBLEM ASSOCIATED WITH THIS EVENT. NO DRUG WAS ASSOCIATED WITH THIS SYSTEM.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION ABOUT THE EVENT REVEALED THE CATHETER HAD PERFORATED WHEN IT WAS CONNECTED TO THE PUMP. THE CATHETER WAS INITIALLY USED WITH/ IN THE PATIENT, BUT REMOVED AND REPLACED WITH ANOTHER CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20340 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1