BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1011373 · Received March 11, 2008

    Report

    Report Number
    6000030-2008-01187
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 9, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S PUMP WAS REPLACED DUE TO POSSIBLE ROTOR FAILURE. NO PT SYMPTOMS WERE REPORTED. A ROTOR STUDY WAS PERFORMED WITH UNCERTAIN RESULTS. A CATHETER DYE STUDY WAS PERFORMED WHICH REVEALED THAT THE CATHETER WAS PATENT. THE PT RECOVERED WITHOUT SEQUELA. THE DRUG CONTAINED IN THE PT'S PUMP WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO IS RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR EXPLANTED,| IMPLANTED:| CATHETER MODEL 8709 LOT# N085026010| PROGRAMMER MODEL PROGRAMMER LOT# UNK| EXPLANTED:| IMPLANTED: