BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1893243 · Received November 1, 2010

    Report

    Report Number
    3004209178-2010-08685
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 6, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    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

    IT WAS REPORTED (B)(6) 2010 THAT THE PT GOT AN ERROR CODE 0616 AND ONE OTHER WHICH STARTED WITH 83_. THE PT REPORTED (B)(6) 2010 THAT HIS PUMP MEDICATION WAS ADJUSTED AND WAS STILL HAVING PROBLEMS WITH THE SYSTEM. THE DOCTOR'S OFFICE REPORTED (B)(6) 2010 THAT THE PT DID NOT KNOW HOW TO USE THE DEVICE AT FIRST. HE WAS TRAINED ON HOW TO PROPERLY USE IT AND THEN IT WORKED FINE. THE DRUGS IN THE PUMP WERE MORPHINE AT 18 MG/ML AND BUPIVACAINE AT 6 MG/ML. THE PT EXPERIENCED IRRITATION WITH HIS PUMP. AT FIRST, THE DOCTOR WAS ATTEMPTING TREAT IT WITH CREAMS AND PATCHES, BUT THEN THE AFFECTED AREA BEGAN THINNING. THERE WAS CONCERN THAT IT WOULD EVENTUALLY BECOME EXPOSED AND THEN INFECTED. THE DOCTOR PERFORMED A REVISION AND PUT A FLAP OVER THE PUMP TO CORRECT THE PUMP. NO TESTS WERE RUN PRIOR TO THE REVISION.

    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 66 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8709SC, LOT # N170501027| PROGRAMMER: MODEL 8835, LOT # NPG014666N| PROGRAMMER: MODEL 8840, LOT # UNK| EXPLANTED:| IMPLANTED:| IMPLANTED: