BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1082990 · Received July 28, 2008

    Report

    Report Number
    6000030-2008-04443
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 1, 2008
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL REPORTED THAT THE PT HAD AN OVERDOSE OF CLONIDINE AND WAS TAKEN BY AMBULANCE TO THE HOSPITAL. THE PT LATER REPORTED THAT THIS WAS THE 3RD EPISODE OF MEDICATION BEING DELIVERED ALL AT ONCE; DATES AND DETAILS OF THE FIRST 2 EPISODES WERE NOT PROVIDED. THE PT WAS UNSURE IF IT WAS DUE TO INJECTING THE MEDICATION INTO THE POCKET SITE OR INTO THE CATHETER ACCESS PORT. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MFG 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R IMPLANTED| PROGRAMMER MODEL PROGRAMMER LOT #UNK| EXPLANTED| CATHETER MODEL 8703W LOT# L35275