BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1812591 · Received August 17, 2010

    Report

    Report Number
    6000030-2010-06183
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 1, 2009
    Report Date
    July 19, 2010
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A GRANULOMA FOUND IN (B)(6)2009. THE PT'S PUMP, AT THAT TIME, DELIVERED A HIGH RATE AND A HIGH CONCENTRATION OF MORPHINE SULFATE (MS). THE PT'S HEALTH CARE PROVIDER (HCP) REDUCED THE CONCENTRATION AND DOSE OF THE MS. IT WAS STATED THAT THE PT HAD LOST "A LOT OF WEIGHT." THE PT THEN HAD ONLY SALINE PLACED IN THE PUMP, AND WAS GIVEN ORAL MORPHINE. ON (B)(6)2010, THE PT EXPERIENCED A NOSE BLEED ("DUE TO THIN BLOOD") AND THE PT'S PUMP BEGAN ALARMING. THE PT EXPERIENCED WITHDRAWAL AFTER THE ORAL MEDICATION RAN OUT. THE PT WAS THEN SEEN BY A NEUROSURGEON WHO STATED THAT A GRANULOMA STILL REMAINED. NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFO WAS REQUESTED BUT UNAVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other IMPLANTED:| CATHETER: MODEL 8703W, LOT# L47429| EXPLANTED: