BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1915511 · Received November 5, 2010

    Report

    Report Number
    3004209178-2010-08955
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    September 17, 2010
    Report Date
    October 15, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IN MFR REPORT # 6000030201008013, THE FOLLOWING INFO WAS REPORTED: IT WAS REPORTED THAT DURING A PUMP IMPLANT/REVISION, THE NEW PUMP WAS FILLED WITH A NEW DRUG CONCENTRATION, MORPHINE 20 MG/ML. THE EXISTING CATHETER WAS UNABLE TO BE ASPIRATED OF THE OLD DRUG CONCENTRATION (MORPHINE 45 MG/DL). THE HEALTH CARE PROVIDER DID NOT TROUBLESHOOT THE CATHETER ISSUE; THE NEW PUMP WAS CONNECTED TO THE EXISTING CATHETER. A PRIMING BOLUS OF 0.199 ML'S RATHER THAN 0.3 ML'S WAS PROGRAMMED ON THE BACK TABLE. OPTIONS FOR "BRIDGING OUT THE OLD 45 MG/ML" IN THE EXISTING CATHETER WERE BEING CONSIDERED. THE PRECEDING PERTAINS TO THIS MFR REPORT'S DEVICE. ALL ADD'L INFO RECEIVED WILL BE REPORTED IN THIS MFR REPORT. ADD'L INFO: AS OF (B)(6) 2010, THE PT WAS "DOING WELL" AND WAS HAVING NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR PROGRAMMER: MODEL 8840, LOT#: UNK| EXPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT#: J11688R17| IMPLANTED:| MODEL 8627L18, LOT#: NGH040786R| IMPLANTABLE INFUSION PUMP: