BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 3230305 · Received July 16, 2013

    Report

    Report Number
    6000030-2013-00185
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    June 21, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT # L57097, IMPLANTED: (B)(6) 1998, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE HEALTHCARE PROVIDER (HCP) WAS NOT ABLE TO FILL THE PUMP WITH 18ML, AND COULD ONLY FILL WITH 15ML. THE REPORTER SPECULATED THAT THE PUMP MAY NOT HAVE BEEN FUNCTIONAL ANYMORE DUE TO NORMAL LONGEVITY, BUT DID NOT KNOW WHY THE PUMP WOULD NOT FILL COMPLETELY. IT WAS LATER REPORTED THE PUMP WAS FROM THE 1990'S AND FAR EXCEEDED ITS LIFE EXPECTANCY, AND WAS SUBSEQUENTLY REPLACED. TO THE REPORTER¿S KNOWLEDGE, THE PATIENT WAS RECEIVING EFFECTIVE THERAPY FOLLOWING THE PROCEDURE, BUT HAD NO FURTHER INFORMATION ON THE CAUSE AND THERE WAS NO FURTHER TROUBLESHOOTING. IT WAS NOTED THAT DURING THE PUMP REPLACEMENT THEY DID NOT CHECK OR CHANGE THE CATHETER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329907 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 861718

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention