BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1180921 · Received September 23, 2008

    Report

    Report Number
    6000030-2008-06051
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 16, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP 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

    THE PATIENT WAS NOT GETTING PAIN RELIEF. A DYE STUDY WAS ATTEMPTED (DATE NOT REPORTED) BUT IT WAS UNSUCCESSFUL. A ROTOR STUDY WAS DONE; THE DATE AND RESULTS WERE NOT REPORTED. THE PUMP WAS REPLACED FOR BATTERY DEPLETION. AT THAT TIME, THE CATHETER WAS FOUND TO BE BLOCKED AT THE PUMP CONNECTOR. THE CATHETER WAS TRIMMED AND THEY HAD FLOW OF CSF. THERE WAS NO PATIENT INJURY. THE PATIENT RECOVERED WITHOUT SEQUELA. THE PUMP WAS USED TO DELIVER DILAUDID (100 MG/ML).

    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 64 YR Required Intervention PROGRAMMER: MODEL PROGRAMMER| EXPLANTED:| CATHETER: MODEL 8709