BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2182211 · Received July 7, 2011

    Report

    Report Number
    3004209178-2011-05184
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S HEALTH CARE PROVIDER WAS HAVING DIFFICULTY ASPIRATING THE RESERVOIR. NORMALLY, THE PUMP IS FILLED WITH 40 CC, BUT THIS TIME, FILLING WAS 20 CC WAS DIFFICULT. ALSO, THE NEEDLE DID NOT SEAT WELL, SO BLOOD TINGED FLUID WAS RETURNED. THE HEALTH CARE PROVIDER RETRIED AND WAS ABLE TO DRAW CLEAR FLUID. IT WAS LATER REPORTED THAT THERE WAS A REFILL PROBLEM. THE HEALTH CARE PROVIDER WAS HAVING DIFFICULTY ACCESSING THE CTR ACCESS PORT. UNDER IMAGING, THE HEALTH CARE PROVIDER ALIGNED WITH THE CTR ACCESS PORT AND WAS ABLE TO PERFORM THE REFILL. THE ISSUE WAS THAT HE WAS TRYING TO ALIGN THE TEMPLATE TO A SUTURE AND NOT THE CTR ACCESS PORT. THE PUMP WAS ABLE TO BE FILLED AND THE PT WAS FINE. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N216439001| IMPLANTED: