BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHROMED EL

    MDR report key: 483449 · Received September 8, 2003

    Report

    Report Number
    6000030-2003-00804
    Event Type
    Other
    Date Received
    September 8, 2003
    Report Date
    September 2, 2003
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP EXPLANTED THE PUMP AND RETURNED IT TO THE MFR FOR ANALYSIS WITH THE COMPLAINT OF "PUMP EXPIRED." A FOLLOW UP REPORT WILL BE SENT WHEN ADDITIONAL INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP LKK RICE CREEK MFG 862718 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other EXPLANTED:UNK.| CATHETER MODEL 8709 LOT# J11491R49 IMPLANTED:2003,