BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3062992 · Received April 17, 2013

    Report

    Report Number
    6000030-2013-00095
    Event Type
    Injury
    Date Received
    April 17, 2013
    Report Date
    March 19, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT # L61551, IMPLANTED: (B)(6) 1999, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2006 THE PATIENT'S PUMP WENT DRY DUE TO THE PATIENT MISSING THE REFILL. THE PATIENT EXPERIENCED WITHDRAWAL AND DELIRIUM TREMENS (DT). IT WAS NOTED THE PUMP WAS OUT OF MORPHINE AND THE PATIENT'S BODY "COULD NOT TOLERATE IT BECAUSE SHE HAS BEEN ON IT SO LONG." THE PATIENT WAS ADMITTED. THE PUMP SYSTEM WAS DELIVERING MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165333 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization