BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 773858 · Received October 24, 2006

    Report

    Report Number
    6000030-2006-01774
    Event Type
    Injury
    Date Received
    October 24, 2006
    Report Date
    September 20, 2006
    Manufacturer
    RICE CREK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED "UNWITNESSED SEIZURES, ELEVATED CARDIAC ENZYMES, NAUSEA, VOMITING AND WEAKNESS. THE HCP REPORTED THAT THE PUMP WAS FILLED WITH MORPHINE SULFATE ON 8/23/06. DOSE AND CONCENTRATION ARE UNK. THE EXPECTED RESERVOIR VOLUME WAS 0.2 ML. THE LOW RESERVOIR VOLUME WAS SET AT 2.0 ML. THE LOW RESERVOIR ALARM DATE WAS 8/23/06. "ALTHOUGH WE DID NOT FILL HER PUMP, IT APPEARS HER PUMP WAS ALLOWED TO RUN DRY". NO PT TREATMENT/INTERVENTION WAS REQUIRED/PERFORMED. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK LKK RICE CREK MFG 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention CATHETER MODEL 8709AA, LOT # J11602R63, IMPLANTED| EXPL