BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3972450 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13798
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: CATHETER; PRODUCT ID 8575, LOT# N092902, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD INCREASED PAIN AND WAS NOT GETTING RELIEF WITH DOSING ADJUSTMENTS. THE PATIENT HAD LESS THAN 50% THERAPY RELIEF IN THEIR BACK. THEY ATTEMPTED TO ASPIRATE FROM THE CATHETER AND IT WAS UNSUCCESSFUL. A "CATHETER ACCESS PORT STUDY" WAS PERFORMED AND RESULTS SHOWED A CATHETER OCCLUSION AND "NO BACK FLOW". THE PUMP WAS USED TO DELIVER FENTANYL. IT WAS FURTHER REPORTED THE PATIENT HAD CHOSEN NOT TO PROCEED WITH ANY FURTHER STUDIES OR SURGERIES. NO SURGICAL INTERVENTION HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449734 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1