BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3070328 · Received April 22, 2013

    Report

    Report Number
    6000030-2013-00097
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    June 6, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# L65390, IMPLANTED: (B)(6) 1999. PRODUCT TYPE: CATHETER: PRODUCT ID 8703W, LOT# L60855, IMPLANTED: (B)(6) 1999. PRODUCT TYPE: CATHETER: PRODUCT ID 8709, LOT# L65390, IMPLANTED: (B)(6) 1999. PRODUCT TYPE: CATHETER: PRODUCT ID 8703W, LOT# L60855, IMPLANTED: (B)(6) 1999. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ALLERGIC TO MORPHINE SO MUCH SO THAT WHEN THE HEALTH CARE PROVIDER (HCP) FIRST PLACED THE MORPHINE, THE PATIENT REACTED SO BAD THAT SHE THREW UP AND IT YANKED THE CATHETER OUT OF THE SPINE. THE PATIENT HAD TO HAVE A CATHETER REVISION AT THAT TIME. IT WAS NOTED THE HCP SECURED IT SO GOOD DURING THE REVISION THAT THE PATIENT HASN'T HAD TO HAVE ANY CATHETER REPLACEMENTS IN 15 YEARS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED FROM THE HEALTH CARE PROVIDER THAT THIS PATIENT NEVER HAD ANYTHING LIKE THAT HAPPEN AND HAD NEVER HAD DEVICE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172698 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627-18

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention