BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 446364 · Received March 6, 2003

    Report

    Report Number
    6000030-2002-00339
    Event Type
    Injury
    Date Received
    March 6, 2003
    Date of Event
    February 12, 2002
    Report Date
    April 8, 2002
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP RETURNED THE PUMP TO THE MANUFACTURER, RECEIVED ON 04/08/2002, DUE TO "NOT FUNCTIONING". THE PT HAD A HISTORY OF GRANULOMA AT CATHETER TIP. 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 54 YR Hospitalization| R CATHETER: MODEL 8709 LOT#J0039980R, IMPLANTED:2000| EXPLANTED: 2002.