BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 667355 · Received January 20, 2006

    Report

    Report Number
    6000030-2006-00095
    Event Type
    Malfunction
    Date Received
    January 20, 2006
    Report Date
    January 11, 2006
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    B5- ADDITIONAL INFORMATION FROM THE HCP REPORTS THE PT WAS ALSO EXPERIENCING INCREASED SPASTICITY. THE PUMP WAS EXPLANTED AND REPLACED ON 02/13/2006. THE PT OUTCOME WAS REPORTED AS "RESOLVED." D7 - PUMP EXPLANTED - 02/13/2006. D11 - DEVICE AVAILABLE FOR EVALUATION - RETURNED TO THE MANUFACTURER ON 02/23/2006. F10 - ADDITIONAL PT CODE - 2357 ADDITIONAL DEVICE CODE - 1217. H6 - DEVICE ANALYSIS RESULTS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PATIENT HAD NOT EXPERIENCED ADEQUATE CONTROL SINCE THE IMPLANT. AT THE LAST REFILL, A VOLUME DISCREPANCY WAS NOTED. THE ESTIMATED RESERVOIR VOLUME WAS 2.0ML AND THE ACTUAL WAS 18.0ML. A ROLLER STUDY DEMONSTRATED A ROLLER STALL. A CATHETHER DYE STUDY SHOWED CATHETER DISLODGEMENT. THE PATIENT IS REPORTED TO BEING MANAGED "BY OTHER MEANS."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE HCP REPORTS THAT DATE OF THE EVENT WAS 12/13/2005. THE PATIENT IS SCHEDULED FOR A REPLACEMENT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP LKK RICE CREEK MANUFACTURING 862718 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention