BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1243712 · Received November 25, 2008

    Report

    Report Number
    6000030-2008-07741
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    September 1, 2008
    Report Date
    October 29, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 AT THE LAST TWO REFILLS, THE PUMP RESERVOIR WAS FULL. NO PATIENT SYMPTOMS WERE REPORTED. THE PUMP WAS REPLACED. THE PUMP WAS USED TO DELIVER HYDROMORPHONE (CONCENTRATION AND DOSAGE WERE NOT PROVIDED). ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 69 YR Required Intervention PROGRAMMER: MODEL PROGRAMMER| CATHETER: MODEL 8709| EXPLANTED:| IMPLANTED: