BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1051717 · Received May 21, 2008

    Report

    Report Number
    6000030-2008-02681
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 19, 2008
    Report Date
    April 21, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0956-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. THE SERIAL NUMBER IS INCLUDED IN THE RANGE 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 PT EXPERIENCED INCREASED PAIN, NAUSEA, HOT AND COLD FLASHES, AND FLU-LIKE SYMPTOMS. THE PT WAS UNABLE TO EAT FOR THREE DAYS, AND HE PRESENTED TO THE ER IN 2008 WHERE HE RECEIVED A SMALL AMOUNT OF PAIN MEDICATION. THE ER DID NOT HAVE A PROGRAMMER TO INTERROGATE THE PUMP. THE PT WAS TOLD HIS PUMP WAS NOT WORKING AND WAS DISCHARGED WITH A DIAGNOSIS OF LOW BACK PAIN. ON TWO DAYS LATER, THE PT WAS SEEN IN THE CLINIC. HE WAS IN EXTREME PAIN, SHIVERING, AND COMPLAINED OF FEELING COLD. THE PUMP WAS INTERROGATED BY A MANUFACTURER'S REPRESENTATIVE AND NO ALARMS WERE SEEN IN THE PUMP PRINTOUTS; THERE WERE NO AUDIBLE ALARMS. THE PT RETURNED TO THE ER AND WAS ADMITTED FOR OBSERVATION. A FLUOROSCOPIC CATHETER DYE STUDY PERFORMED THE NEXT DAY SHOWED THAT THE PROXIMAL AND DISTAL CATHETER WERE PATENT. A ROLLER STUDY SHOWED NO ROLLER MOVEMENT. PUMP REPLACEMENT SURGERY SCHEDULED ON TWO DAYS LATER WAS CANCELLED AND THE PT WAS ADMITTED TO THE CORONARY CARE UNIT. THE PUMP WAS REPLACED 2 DAYS LATER. NO PT OUTCOME WAS REPORTED. THE PUMP WAS USED TO DELIVER MORPHINE. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    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 55 YR Hospitalization| L| R CATHETER MODEL 8731 LOT# B005592N58| EXPLANTED:| MPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT# UNK