BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1465940 · Received July 22, 2009

    Report

    Report Number
    6000030-2009-05031
    Event Type
    Malfunction
    Date Received
    July 22, 2009
    Date of Event
    June 1, 2009
    Report Date
    June 25, 2009
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    AN OVERDOSE WAS REPORTED. THE HEALTH CARE PROVIDER (HCP) STATED THAT THE "PT IS GETTING TOO MUCH MEDICATION" AND THE PT "IS DIFFICULT TO AROUSE." THE ER PHYSICIAN WANTED TO STOP THE PUMP. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT # UNK| CATHETER: MODEL 8713, LOT # B005906N58