BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1081359 · Received July 24, 2008

    Report

    Report Number
    6000030-2008-04274
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 24, 2008
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1149-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD SURGERY TO REMOVE A GRANULOMA AT THE TIP OF THE CATHETER. CT WAS UTILIZED DURING SURGERY TO LOCATE THE GRANULOMA. THE CATHETER TIP WAS SENT TO THE LAB FOR ANALYSIS. THE PT RECOVERED FROM SURGERY, AND WAS "SLOWLY RETURNING TO NORMAL".

    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 Required Intervention CATHETER MODEL #: 8709 LOT#: J0177997R IMPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT# UNK| EXPLANTED: