BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1052340 · Received May 27, 2008

    Report

    Report Number
    6000030-2008-02823
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    March 1, 2008
    Report Date
    April 25, 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 COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT 2 CONSECUTIVE PUMP REFILLS ALL THE MEDICATION PLACED AT THE PREVIOUS REFILL VISIT WAS REMOVED FROM THE PUMP RESERVOIR. THE PUMP WAS NOT RUNNING PROPERLY AND THE PT RECEIVED NO THERAPY FOR 2 MONTHS. A ROTOR STUDY WAS PERFORMED AND THE ROTOR DID NOT MOVE. A CATHETER DYE STUDY WAS PERFORMED AND THE CATHETER WAS INTACT (DATE OF EXAMS NOT REPORTED). THE COMPANY REP WAS TOLD THE PUMP WOULD BE REPLACED DUE TO BATTERY DEPLETION. PREOPERATIVELY THE PUMP SCREEN WAS ACTIVE; THE PUMP LOGS SHOWED NO BATTERY ALARM THEN OR FROM THE PREVIOUS REFILL. AT PUMP REPLACEMENT, THE ENTIRE CONTENTS OF THE OLD PUMP WERE TRANSFERRED TO THE NEW PUMP, VERIFYING THE LACK OF INFUSION. A LOW BATTERY ALARM DID APPEAR AFTER EXPLANT. THE PUMP WAS REPLACED. THE PT OUTCOME WAS REPORTED AS 'NO INJURY, RECOVERED WITHOUT SEQUELA.' THE PUMP WAS USED TO DELIVER FENTANYL, BUPIVACAINE, CLONIDINE, AND BACLOFEN. 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention PROGRAMMER MODEL PROGRAMMER LOT# UNK| IMPLANTED:| CATHETER MODEL 8709 LOT# J11468R29| EXPLANTED: