BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 405656 · Received July 17, 2002

    Report

    Report Number
    6000030-2002-00509
    Event Type
    Injury
    Date Received
    July 17, 2002
    Report Date
    July 16, 2002
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HCP REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SYMPTOMS OF FLUSHING, ELEVATED BLOOD PRESSURE, AND PALPITATIONS. THE HCP IS THINKING THIS MAY BE WITHDRAWAL, BUT THE PATIENT NEVER COMPLAINED OF INCREASED PAIN. ON 07/2002 THE PATIENT WAS SEEN IN THE CLINIC AND STARTED ON ORAL ANALGESICS AND A LOW DOSE DURAGESIC PATCH. THE TELEMETRY ON THE PUMP WAS FINE. THERE WERE CORRECT RESIDUALS AND THE PUMP BATTERY WAS OK. THE PATIENT WAS BETTER A FEW DAYS LATER. PATIENT WAS SEEN ON 07/2002 FOR A REFILL AND THE SYMPTOMS CONTINUED TO IMPROVE. THE HCP IS CONSIDERING PUMP AND CATHETER STUDIES IF THE PATIENT CONTINUES TO HAVE PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL IMPLANTABLE INFUSION PUMP LKK MEDTRONIC, INC. 862618 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization CATHETER: MODEL 8709, LOT# L59233, IMPLANTED: 1999| EXPLANTED: UNK.