BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 2983494 · Received February 28, 2013

    Report

    Report Number
    6000030-2013-00042
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 1, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8703W, LOT# L41566, IMPLANTED: (B)(6) 1996, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS TURNED OFF A COUPLE OF YEARS AFTER INITIAL IMPLANT DUE TO THE PUMP WAS ALWAYS TURNING, AND THE HEALTH CARE PROVIDER (HCP) HAD DIFFICULTIES REFILLING IT. THE PUMP SYSTEM WAS USED TO DELIVER DILAUDID. 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
    86566 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1