BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1081360 · Received July 24, 2008

    Report

    Report Number
    6000030-2008-04273
    Event Type
    Injury
    Date Received
    July 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: USED FOR THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS DISCONNECTED FROM THE PUMP; CONFIRMED BY A CATHETER DYE STUDY. NO PT SYMPTOMS WERE REPORTED. THE PT UNDERWENT A PUMP REPLACEMENT IN 2008. IT IS UNK IF THE CATHETER WAS REVISED OR REPLACED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 EXPLANTED:| CATHETER MODEL #: 8709 LOT#: L57096 IMPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT# UNK