BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED EL

    MDR report key: 1053115 · Received May 28, 2008

    Report

    Report Number
    6000030-2008-02855
    Event Type
    Death
    Date Received
    May 28, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 30, 2008
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. THE SERIAL NUMBER IS INCLUDED IN THE RANGE FOR THE SYNCHROMED EL PUMP MOTOR STALL DUE TO GEAR SHAFT WEAR MFG BEGINNING SEPTEMBER 1999 PHYSICIAN COMMUNICATION (DATED AUGUST 2007).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS LAST SEEN IN CLINIC IN 2008 AND HAD AN INTRATHECAL LIORESAL CONCENTRATION OF 2000 MCG/ML AT A DOSE WAS 195 MCG/DAY WITH REFILLS EVERY 3 MONTHS. THE PUMP WAS LAST REFILLED ON APPROX THREE MONTHS LATER, WITH THE SAME CONCENTRATION AND DOSE. THE PT EXPIRED APPROX 3 WEEKS LATER. THE PARAMEDICS WERE CALLED TO THE PT'S HOME. THE PT WAS FOUND WITH "CLEAR PURGE EMITTING FROM HER NOSE AND MOUTH". THE PT HAD A TUBE INSERTED INTO HER STOMACH FOR "EXTRABUCCAL FEEDING". NO PULSE OR RESPIRATIONS WERE PRESENT. THE PUPILS WERE NON-RESPONSIVE TO DIRECT LIGHT. THE PT'S DISEASE HAD STEADILY PROGRESSED UNTIL SHE WAS UNABLE TO MOVE AND BEDRIDDEN IN 1998. IN 2003, SHE STOPPED TALKING. IN 2005, SHE NO LONGER RECOGNIZED HER FAMILY AND HAD NO COGNITIVE FUNCTION. SHE REMAINED AT HOME UNTIL HER DEATH. IT HAD BEEN SUGGESTED BY THE HCP THAT THE PUMP BE REPLACED. THE PT'S HUSBAND OPTED NOT TO REPLACE THE PUMP FEARING THAT HIS WIFE WOULD NOT SURVIVE THE SURGERY. AN AUTOPSY WAS BEING PERFORMED. THE CORONER REPORTED THAT ASPIRATION WAS A POSSIBLE CAUSE OF DEATH. TOXICOLOGY TESTING WAS BEING PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MFG 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death PROGRAMMER: MODEL PROGRAMMER, LOT # UNK| CATHETER: MODEL 8703W, LOT # L43272| IMPLANTED:| EXPLANTED: