BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 2910494 · Received January 11, 2013

    Report

    Report Number
    6000030-2013-00008
    Event Type
    Injury
    Date Received
    January 11, 2013
    Report Date
    December 19, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT # J10943R08, IMPLANTED: (B)(6) 2001, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2010, THE PATIENT REQUESTED TO HAVE THE PUMP TURNED OFF. AT THIS TIME, THE PUMP DELIVERED MORPHINE. THE PATIENT WAS NOT TITRATED AND THE DOCTOR TURNED THE PUMP OFF. THE PATIENT WAS UNSURE IF THE MEDICATION WAS ALLOWED TO RUN OUT OR IF SALINE WAS PUT IN THE PUMP. AFTER TURNING THE PUMP OFF, THE PATIENT EXPERIENCED WITHDRAWAL FOR 5 DAYS. SYMPTOMS INCLUDED NAUSEA AND THE PATIENT'S LEGS "WOULDN'T STAY STILL." THE PATIENT WAS HOSPITALIZED FOR 3 DAYS FOR THE EVENT. THE PATIENT WAS GIVEN A PATCH ON THE ARM FOR THE NAUSEA. THE PATIENT STATED "IT WAS BAD." THE PATIENT'S CURRENT STATUS WAS "ALRIGHT" EXCEPT FOR SOME PAIN IN THE BACK. THE PATIENT WAS CURRENTLY HEARING THE PUMP ALARM "EVERY COUPLE OF MINUTES OR SO." THE PATIENT WAS TO HAVE THE PUMP INTERROGATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16543 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627-18

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization