BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1081355 · Received July 24, 2008

    Report

    Report Number
    6000030-2008-04254
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    May 8, 2008
    Report Date
    June 24, 2008
    Manufacturer
    RICE CREEK MANUFACTRING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: USED FOR THE CATHETER WHICH WAS NOT RETURNED FOR ANALYSIS. PUMP ANALYSIS REVEALS NO ANOMALY FOUND - NORMAL DEVICE FUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED INCREASED PAIN. IN 2008, A CLOSE ADJUSTMENT WAS DONE WITH NO CHANGE IN PAIN LEVEL. A CATHETER OBSTRUCTION WAS NOTED DURING A CATHETER DYE STUDY NOTED BELOW. THE ENTIRE SYS WAS EXPLANTED AND REPLACED THE FOLLOWING DAY. THE PT CONTINUES TO COMPLAIN OF PAIN IN BACK AND ALL EXTREMITIES WHICH IS CONSIDERED NORMAL FOR THE PT. THE HLTH CARE PROVIDERS DID REDUCE THE DOSE OF HER INTRATHECAL MEDICATIONS AT THE TIME OF THE SURGERY TO PREVENT OVERDOSE AS THE CATHETER HAD BEEN OBSTRUCTED (REDUCED TO BACLOFEN=174.29 MCG/DAY;CLONIDINE=124.29 MCG/DAY;HYDROMORPHONE=7 MG/DAY).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention CATHETER MODEL# 8709 LOT# L71603| IMPLANTED| PROGRAMMER MODEL PROGRAMMER LOT # UNK| EXPLANTED