BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1060657 · Received June 13, 2008

    Report

    Report Number
    6000030-2008-03247
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    March 13, 2008
    Report Date
    May 14, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - USED FOR CATHETER. CATHETER NOT RETURNED. PUMP ANALYSIS WAS NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT BEGAN EXPERIENCING INCREASED PAIN AND WAS THOUGHT TO BE "GOING INTO WITHDRAWAL." THE PT HAD AN INTRATHECAL DRUG DELIVERY SYS IMPLANTED FOR TREATMENT OF POSTLAMINECTOMY SYNDROME OF THE LUMBAR SPINE. THE DRUG USED IN THE PUMP WAS MORPHINE 10 MG/ML AT A DOSE OF 1.5 MG/DAY. A SIDE PORT ACCESS WAS ATTEMPTED TO ASPIRATE CSF AND CHECK FOR CATHETER PATENCY AND MICROFRACTURES. THE HEALTHCARE PROVIDER WAS UNABLE TO ASPIRATE CSF FROM THE SIDE PORT OF THE PUMP. A PROBLEM WITH THE DISTAL PORTION OF THE CATHETER WAS SUSPECTED. THE PT WAS SCHEDULED FOR REVISION SURGERY IN 2008. DURING THE REVISION PROCEDURE, THE DISTAL PORTION OF THE CATHETER WAS FOUND TO BE FUNCTIONING APPROPRIATELY. NO EXPLORATION OF THE PROXIMAL PORTION WAS DONE AT THAT TIME. THE PT'S MORPHINE DOSE WAS INCREASED TO 2 MG/DAY. DESPITE THE INCREASE, THE PT CONTINUED TO HAVE SIGNIFICANT PROBLEMS WITH SYMPTOMS "CONSISTENT WITH WITHDRAWAL." ONE WEEK LATER, THE PT UNDERWENT A ROLLER STUDY PROCEDURE ON THE PUMP. THE ROLLER MOVED 90 DEGREES AND IT WAS DETERMINED TO BE WORKING. A FLUOROSCOPIC EXAM OF THE REMAINDER OF THE CATHETER WAS PERFORMED. NO FRACTURES OR OBVIOUS KINKING WERE SEEN. THE PT'S DOSE WAS INCREASED TO 2.5 MG/DAY, AND THE PT RETURNED HOME TO SEE IF THE SYMPTOMS IMPROVED. ONE WEEK LATER, THE PT RETURNED TO THE OFFICE STILL HAVING PROBLEMS WITH PAIN CONTROL AND FELT LIKE SHE WAS GOING THROUGH "WITHDRAWAL SYMPTOMS." SYMPTOMS REPORTED INCLUDED NAUSEA AND INCREASED PAIN. THE DECISION WAS MADE TO EXPLORE THE PUMP POCKET AND POSSIBLY REPLACE THE PUMP AS IT HAD BEEN IN PLACE FOR FIVE YRS. DURING THE PROCEDURE, THE PUMP WAS REMOVED AND THE CATHETER DISCONNECTED FROM THE SIDE PORT OF THE PUMP. AT THAT TIME THERE WAS GOOD CSF FLOW COMING FROM THE DISCONNECTED CATHETER INDICATING THE CATHETER, IN ITS ENTIRETY, WAS PATENT. THE CONNECTOR PIECE OF THE CATHETER WAS TRIMMED AND CONNECTED TO THE NEW PUMP. THE DOSE OF MORPHINE WAS RETURNED TO 1.740 MG/DAY.

    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 61 YR Required Intervention IMPLANTED| CATHETER MODEL 8709 LOT #J11518R48| EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT#UNK