BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1061417 · Received June 17, 2008

    Report

    Report Number
    6000030-2008-03306
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    July 1, 2007
    Report Date
    June 16, 2008
    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

    THE SERIAL NUMBER IS INCLUDED IN THE RANGE FOR THE SYNCHROMED EL PUMP MOTOR STALL DUE TO GEAR SHAFT WEAR MANUFACTURED BEGINNING SEPTEMBER 1999 PHYSICIAN COMMUNICATION (DATED AUGUST 2007).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP "FAILED" AND THE PATIENT EXPERIENCED BACLOFEN WITHDRAWAL IN 2007. THE PUMP WAS SUBSEQUENTLY REPLACED. NO OTHER INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention IMPLANTED:| CATHETER MODEL CATHETER LOT# UNKNOWN| PROGRAMMER MODEL PROGRAMMER LOT# UNKNOWN| EXPLANTED,