BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2762966 · Received September 27, 2012

    Report

    Report Number
    3004209178-2012-08616
    Event Type
    Injury
    Date Received
    September 27, 2012
    Report Date
    September 4, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    8709SC, S/N: (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, 8578 L/N: N153694 IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DRUG DELIVERY SYSTEM WAS REMOVED DUE TO WOUND DEHISCENCE AND EXPOSED CATHETER. CONSERVATIVE MEASURES WERE NOT ABLE TO SAFELY PRESERVE THE IMPLANT. (B)(6) INFECTION WAS ALSO REPORTED. FLANK INCISION WAS THE HALLWAY POINT FOR THE EXTERNALIZATION OF THE CATHETER PASSING. MEDICAL STAFF THOUGHT IT WAS PRESERVED AFTER A MINOR DEHISCENCE AFTER SURGERY BUT HAD QUICKLY CLOSED. IT SUDDENLY OPENED WIDE. PATIENT HAS BEEN MISERABLE WITH THE LACK OF PAIN RELIEF FROM IT PUMP. A NEW SYSTEM WILL BE IMPLANTED IN APPROXIMATELY SIX WEEKS. DRUGS INFUSED: PRIALT AND DILAUDID

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention