BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3203570 · Received July 3, 2013

    Report

    Report Number
    3004209178-2013-04754
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    August 22, 2012
    Report Date
    August 22, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    A PROBLEM WAS REPORTED. HEALTH CARE PROFESSIONAL REPORTED DIFFICULTY FILLING AND OR ASPIRATING THE RESERVOIR ALONG WITH PATIENT ITCHING SENSATION NEAR NEEDLE STICK. HCP REPORTED THEY WERE ABLE TO ASPIRATE THE RESERVOIR, BUT UNABLE TO FILL IT COMPLETELY. THEY WERE ABLE TO PUSH IN 10 ML OF DRUG BEFORE THEY MET RESISTANCE. THEY THEN ASPIRATED THE 10 ML OF DRUG FROM THE RESERVOIR. THE HCP STATED THAT THE NEEDLE MAY HAVE SLIPPED OUT OF THE REFILL PORT WHEN ASPIRATING. EVENTUALLY THEY WERE ABLE TO GET 40 ML OF FLUID IN THE SYRINGE. FOLLOW UP INFORMATION HAS BEEN REQUESTED BUT NO ADDITIONAL INFORMATION HAD BEEN PROVIDED AS OF THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A REPORT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306450 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR