BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1023433 · Received April 2, 2008

    Report

    Report Number
    6000030-2008-01730
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 3, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER IS INCLUDED IN THE RANGE FOR SYNCHROMED EL PUMP MOTOR STALL DUE TO GEAR SHAFT WEAR MANUFACTURED BEGINNING 1999 PHYSICIAN COMMUNICATION (DATED 2007). PUMP MOTOR STALL HAS NOT BEEN CONFIRMED IN THIS DEVICE.

    Description of Event or Problem · 1

    THE HCP REPORTED A VOLUME DISCREPANCY. THE EXPECTED RESERVOIR VOLUME WAS 2 ML; THE ACTUAL RESERVOIR VOLUME WAS 17 ML. THE PT HAD A LOSS OF THERAPEUTIC EFFECT. THERE WERE NO ALARMS AND NO DIAGNOSTIC STUDIES HAD BEEN COMPLETED. THE PT WAS AT THE CLINIC AT THE TIME OF THE REPORT. THE PUMP WAS USED TO DELIVER DILAUDID. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER MODEL 8709 LOT # J11295R56 IMPLANTED| EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT # UNK IMPLANTED| EXPLANTED