BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1872807 · Received October 14, 2010

    Report

    Report Number
    3004209178-2010-07947
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    August 29, 2010
    Report Date
    September 16, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    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

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN UNDERDOSE. PATIENT REPORTED SYMPTOMS OF "ELECTRICITY SHOOTING DOWN HER LEGS" AND YAWNING AND SNEEZING AT THE SAME TIME. PATIENT STARTED SHOWING SYMPTOMS (B)(6)2010 EARLY IN THE MORNING AND WAS ADMITTED TO HOSPITAL AT 3:00 AM. THE PATIENT HAD SYMPTOMS OVER THE ENTIRE SYSTEM. AN MRI WAS DONE (B)(6)2010. CALLER INDICATED THEY HEARD A CHIRPING NOISE COMING FROM THE PUMP, 2X ON (B)(6)2010 AND ONE TIME ON (B)(6)2010. THE REFILL DATE WAS IN OCTOBER. SYMPTOMS WERE IN THE LEFT LEG, RIGHT LEG AND NEAR THE CATHETER PATHWAY. LOGS WERE CHECKED BY THE COMPANY REPRESENTATIVE AT HCP OFFICE AND INDICATED THAT THERE WERE NO REPORTS OF ANY ERRORS. THE REPRESENTATIVE TOLD THE PATIENT THAT THE PUMP WAS FINE. A DYE STUDY WAS REPORTED (B)(6)2010. TWO DYE STUDIES HAD BEEN PERFORMED IN THE PAST AND THE DYE MOVED THROUGH THE CATHETER. CALLER STATED WHEN HCP APPLIED PRESSURE FROM SYRINGE, IT GOT DYE THROUGH SYSTEM AND CATHETER, BUT WHEN RELYING ON PUMP (AND HCP WAS NOT APPLYING PRESSURE) FLUID DID NOT GET THROUGH SYSTEM. A RADIOLABELED INDIUM STUDY WAS PERFORMED. AN IMAGE WAS TAKEN WHICH SHOWED FLUID HAD MADE ITS WAY THROUGH PUMP TO THE PORT AREA. ANOTHER 24 HRS WOULD TELL IF FLUID GOT TO THE CATHETER PORT AND CATHETER. PATIENT STATED RADIOLOGIST WAS ALSO PERFORMING A MYELOGRAM AND COULD NOT INJECT INTO THE CATHETER ACCESS PORT. CALLER STATED PATIENT AND THE NURSE HEARD A CHIRPING SOUND FROM THE PUMP. THE DOSAGE OF PUMP PRIOR TO IMPLANT WAS MORPHINE AT 16 AND BACLOFEN AT 300. WITH REPLACEMENT PUMP DOSAGE WAS DECREASED TO MORPHINE AT 8 AND BACLOFEN AT 99. HCP DOES NOT WANT TO GO HIGHER THAN MORPHINE AT 11 AND BACLOFEN AT 99. THE PUMP CONTAINED "BACLOFEN AND MORPHINE COMPOUNDED". THE PATIENT UNDERWENT AN INDIUM STUDY REVEALING A SMALL CATHETER FRACTURE. THE CATHETER WAS REPLACED ON (B)(6)2010. THERE WERE NO CONCERNS FROM THE TREATING PHYSICIAN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8731, LOT #N004615825