BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1031187 · Received April 18, 2008

    Report

    Report Number
    6000030-2008-02060
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    December 1, 2007
    Report Date
    March 20, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER IS INCLUDED IN THE RAGE FOR 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

    THE PATIENT REPORTED THAT THE PUMP STOPPED WORKING 4 MONTHS AFTER IMPLANT AND HE EXPERIENCED AN UNDER DOSE (SPECIFIC SYMPTOMS NOT REPORTED). HE FURTHER REPORTED THAT HIS HCP WAS ON VACATION AT THE TIME; WHEN HE WENT TO THE EMERGENCY ROOM THE CARE PROVIDERS WERE UNSURE HOW TO MANAGE HIS PUMP OR HIS CONDITION. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS CALLING FROM HIS HOME AND REPORTED HIS STATUS AS FAIR. THE PUMP WAS USED TO DELIVER FENTANYL AND BUPIVACAINE, AND HAD BEEN TURNED OFF FOR 2 MONTHS AT THE TIME OF THE CALL. THE PATIENT WOULD LIKE THE PUMP REMOVED WHEN HE CAN FIND AN HCP TO TAKE CARE OF THIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 Hospitalization| R IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER MODEL 8709 LOT# L77604| EXPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT# UNK