BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3203538 · Received July 3, 2013

    Report

    Report Number
    3007566237-2013-01141
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    August 14, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN. PRODUCT TYPE: CATHETER: PRODUCT ID NEU_ UNKNOWN_CATH, SERIAL# UNKNOWN. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CATHETER REVISION FOR AN UNSPECIFIED ISSUE. DIAGNOSTICS WERE PERFORMED INCLUDING AN X-RAY, CT SCAN AND INDIUM DYE STUDY. NONE OF THE TEST RESULTS SHOWED A CATHETER MALFUNCTION. THE PUMP WAS SET TO MINIMUM RATE AND THE PATIENT WAS GIVEN AN EXTERNAL INJECTION OF BACLOFEN WHICH WAS SUCCESSFUL. THE SURGEON DECIDED TO REVISE THE CATHETER; HOWEVER, WHEN THE 2-PIECE CATHETER WAS TAKEN APART, CEREBRAL SPINAL FLUID (CSF) BACKFLOW WAS OBSERVED FROM THE SPINAL SEGMENT OF THE CATHETER AND THEY WERE ABLE TO ASPIRATE. IT WAS DECIDED THAT THE ENTIRE CATHETER BE REPLACED; HOWEVER, THE SURGEON WAS UNABLE TO RETRIEVE THE SPINAL SEGMENT OF THE CATHETER BECAUSE HE DID NOT GO INTO THE SAME INCISION LINE DUE TO THE PATIENT¿S HISTORY OF CELLULITIS. THEREFORE, THE CATHETER WAS LEFT IN THE PATIENT AND TIED OFF. THE PATIENT CURRENTLY HAS 2 CATHETERS IMPLANTED. PATIENT OUTCOME WAS NOT PROVIDED. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303946 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention