BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1035640 · Received April 29, 2008

    Report

    Report Number
    2182207-2008-02315
    Event Type
    Injury
    Date Received
    April 29, 2008
    Report Date
    April 2, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: WALLACE MS, RAUCK R, FISHER R, CHARAPATA SG, ELLIS D, DISSANAYAKE S. "INTRATHECAL ZICONOTIDE FOR SEVERE CHRONIC PAIN: SAFETY AND TOLERABILITY RESULTS OF AN OPEN-LABEL, LONG-TERM TRIAL." ANESTH ANALG 2008;106(2):628-637. THE PRIMARY OBJECTIVE OF THE CURRENT STUDY WAS TO INVESTIGATE THE SAFETY AND TOLERABILITY OF LONG-TERM ZICONOTIDE THERAPY USING A SLOW-TITRATION REGIMEN. THIS OPEN-LABEL, MULTICENTER, LONG-TERM, OUTPATIENT STUDY EVALUATED THE EFFICACY, SAFETY, AND TOLERABILITY OF IT ZICONOTIDE IN 644 PTS WITH SEVERE CHRONIC PAIN, WITH A PRIMARY FOCUS ON SAFETY AND TOLERABILITY. A TOTAL OF 744 INFUSION PUMPS WERE ASSOCIATED. SOME PTS HAD BOTH A MEDTRONIC IMPLANTABLE PUMP AND A CADDMICRO AMBULATORY INFUSION PUMP, SIMS DELTEC, INC. EVENT: ONE CASE OF MENINGITIS WAS REPORTED WITH AN IMPLANTED INFUSION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK MEDTRONIC NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O PROGRAMMER MODEL UNK| IMPLANTABLE SYNCHROMED INFUSION PUMP MODEL UNK