BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3800054 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08720
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE MANUFACTURING REPRESENTATIVE WAS PREPPING THE PUMP IT WAS DIFFICULT AND SLOW, BUT THEY WERE ABLE TO ASPIRATE ALL 40 CC FROM THE RESERVOIR. THE REPORTER STATED THEY DID NOT TRY TO FILL THE RESERVOIR WITH DRUG YET. THE REPORTER FURTHER STATED THAT WHEN THEY INJECTED SALINE THROUGH THE CATHETER ACCESS PORT (CAP) THEY USED A LOT OF PRESSURE AND FORCE, BUT IT DRIPPED OUT AND DID NOT FLOW LIKE IT USUALLY DID. IT WAS NOTED THAT THE OPERATING ROOM WAS VERY COLD. THE PUMP CONTAINED GABLOFEN (BACLOFEN). ADDITIONAL INFORMATION RECEIVED REPORTED THE MANUFACTURING REPRESENTATIVE WAS ABLE TO COMPLETELY ASPIRATE AND FILL THE PUMP. THE REPORTER STATED THEY SWITCHED NEEDLES TO FLUSH THE CAP AND IT FLUSHED PERFECTLY. IT WAS NOTED THE PATIENT LEFT THE OPERATING ROOM IN SATISFACTORY CONDITION. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278737 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR