BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1892398 · Received November 3, 2010

    Report

    Report Number
    3004209178-2010-08811
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    September 27, 2010
    Report Date
    February 17, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CATHETER HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD HER CATHETER REVISED. AFTER THE REVISION, IT WAS REPORTED THE PATIENT'S HEALTH CARE PROVIDER (HCP) BELIEVED THE PATIENT WAS RECEIVING "TO MUCH" MEDICATION, AND REDUCED HER PUMP'S DELIVERY RATE. IT WAS STATED THE PATIENT EXPERIENCED "LOW OXYGEN SATURATIONS, NAUSEA, AND WAS DROWSY." THE HCP BELIEVED THE CONCENTRATION OF DRUG WAS "TOO HIGH," SO THE PUMP AND CATHETER WERE COMPLETELY FLUSHED OF THE MEDICATION, AND WERE REPLACED WITH A LOWER CONCENTRATION OF MEDICATION. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS MORPHINE, THE ORIGINAL CONCENTRATION WAS 50MG/ML, AND THE NEW CONCENTRATION WAS 10MG/ML. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 42 YR Female Hospitalization| R CATHETER: MODEL 8578, LOT# N222590011| CATHETER: MODEL 8709SC, LOT# J11453R39| CATHETER: MODEL 8709SC, LOT# N259863004| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 863740| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LOT# NGV007626N| IMPLANTED:| LOT# NGV007626N| CATHETER: MODEL 8709SC, LOT# N259863004| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J11453R39| CATHETER: MODEL 8578, LOT# N222590011| IMPLANTED:| EXPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 863740