BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 2003751 · Received February 24, 2011

    Report

    Report Number
    6000030-2011-01404
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 18, 2011
    Report Date
    February 9, 2011
    Manufacturer
    RICE CREEK MANUFACTURUING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP AND CATHETER HAVE 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 PUMP AND CATHETER WERE REPLACED. THE PUMP REPLACEMENT WAS DUE TO END OF LIFE AND THE CATHETER REPLACEMENT WAS DUE TO AN OCCLUSION. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS DIRECTLY RELATED TO HIS DEVICE PRIOR TO ITS REPLACEMENT. THE PATIENT'S PAIN WAS UNDER CONTROL WITH THE NEW DEVICE SYSTEM. THE PUMP WAS USED TO DELIVER MORPHINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# J11767R15