BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1936191 · Received December 14, 2010

    Report

    Report Number
    6000030-2010-10456
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    April 30, 2008
    Report Date
    June 11, 2010
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP AND CATHETER WERE REPLACED. THE PUMP WAS ALARMING DUE TO BATTERY DEPLETION/END OF SERVICE. THE REASON FOR REPLACING THE CATHETER WAS NOT PROVIDED. THE OUTCOME WAS RESOLVED WITHOUT SEQUELA. THE PUMP WAS USED TO DELIVER MORPHINE.

    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 45 YR Required Intervention CATHETER: MODEL 8711, LOT# J11471R07| EXPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT# UNKNOWN| IMPLANTED: