BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1222423 · Received November 5, 2008

    Report

    Report Number
    6000030-2008-07223
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 10, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WOULD "FEEL WITHDRAWAL WITH EVERY CLOSE APPROXIMATION TO HER REFILL". THE PHYSICIAN REPORTED THIS WAS PROBABLY DUE TO THE PUMP BEING OVER 5 YEARS OLD. THE PUMP WAS EXPLANTED AND REPLACED IN 2008. THE DRUGS USED IN THE PUMP WERE HYDROMORPHONE 30.0 MG/ML AT A DOSE OF 10.983 MG/DAY AND BACLOFEN 500 MCG/ML (DOSE NOT REPORTED). THE INFUSION MODE WAS SIMPLE CONTINUOUS AT AN INFUSION RATE OF 0.3661 ML. NO OUTCOME OR SPECIFIC SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 30 YR Required Intervention PROGRAMMER MODEL PROGRAMMER LOT# UNKNOWN| CATHETER MODEL 8709 LOT# J11489R41| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| CATHETER MODEL 8598 LOT# N004662704