BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3771336 · Received April 24, 2014

    Report

    Report Number
    3004209178-2014-08085
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    April 4, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A CONSTANT ONGOING HEADACHE ¿FOR SOME TIME NOW¿ AND REPORTED BEING ¿CLAMMY.¿ IT WAS NOTED THE PATIENT HAD A REFILL YESTERDAY AND ON THE DATE OF THIS REPORT WERE GOING TO DO CATHETER ACCESS PORT (CAP) ACCESS AND CHECK FOR A POTENTIAL INFECTION. IT WAS ALSO REPORTED THE PATIENT¿S HUSBAND STATED THE PATIENT WAS TOO SICK TO COME INTO HER NORMAL PHYSICIAN¿S OFFICE BECAUSE THEY LIVE 90 MINUTES AWAY. THE PATIENT WAS REFERRED TO THE LOCAL EMERGENCY ROOM (ER). IT WAS NOTED THE PATIENT HAD A HEAD INJURY ONE YEAR AGO AND HAD A SUBDURAL HEMATOMA BECAUSE OF IT. THE HEAD INJURY WAS DUE TO ¿SOME TYPE OF INJURY¿ AND NOT PUMP RELATED. IT WAS FURTHER REPORTED THE CAP STUDY TOOK PLACE ON 2014-(B)(6) AND THREE SAMPLES OF CEREBROSPINAL FLUID (CSF) WERE SENT TO PATHOLOGY AND THE SAMPLES ¿WERE CLEAR.¿ A COMPLETE BLOOD COUNT (CBC) ALREADY CAME BACK NEGATIVE AND THE PHYSICIANS AT THE PREVIOUS HOSPITAL THOUGHT IT WAS UNNECESSARY TO DO A LUMBAR PUNCTURE (LP) SINCE IT COULD BE DONE SIMPLY WITH THE CAP. THE PATIENT¿S MANAGING PHYSICIAN WANTED TO DO THE LP ANYWAY. IT WAS NOTED THE PUMP WAS NOT SUSPECTED TO BE A PROBLEM; RATHER IT WAS BEING USED AS A TOOL TO FIGURE OUT WHAT WAS WRONG WITH THIS PATIENT. THE PUMP WAS BEING USED TO DELIVER HYDROMORPHONE, CLONIDINE, BUPIVACAINE, AND SUFENTANYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249106 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention