BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3923621 · Received July 9, 2014

    Report

    Report Number
    6000030-2014-00091
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 17, 2014
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, LOT# J11163R46, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE AND THE HCP (HEALTHCARE PROVIDER) OFTEN SAID ¿COME IN IF YOU ARE STILL IN PAIN¿ AND THEY WOULD ¿BUMP UP THE PUMP¿. THIS IRRITATED THE PATIENT. IT GOT TO THE POINT WHERE THE PATIENT HAD TO ¿GET A REFILL EVERY 3-4 DAYS¿ BECAUSE OF PAIN AT THAT TIME. THE PATIENT STATED THAT AFTER SURGERY HE DID NOT HAVE NEARLY AS MUCH PAIN AND GOT A REFILL ¿IN A BETTER PART OF THE MONTH¿. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399890 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention