BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2903334 · Received January 9, 2013

    Report

    Report Number
    3004209178-2013-00325
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 13, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, LOT# N196416006, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED HEADACHES, ITCHING, CRYING OFTEN, AND FEELING LIKE HE WAS GOING CRAZY. HE INDICATED THAT HIS SYMPTOMS BEGAN APPROXIMATELY ONE WEEK BEFORE HE REPORTED THEM. HE STATED THAT HE MISSED HIS LAST REFILL APPOINTMENT AND HE DID NOT REMEMBER WHEN HIS LAST REFILL DATE WAS SCHEDULED. THE PATIENT ALSO REPORTED THAT HE WENT TO THE HOSPITAL TWO DAYS BEFORE, WHERE HE RECEIVED HEART MEDICATION. HE HAD BEEN PRESCRIBED OXYCODONE AND TAKES ONE PILL EVERY FOUR HOURS. HE ALSO TAKES VALIUM TWO TIMES PER DAY, AND REPORTED THAT THE VALIUM WAS NOT HELPING HIM WITH HIS SYMPTOMS. THE PATIENT INDICATED THAT HIS BACLOFEN PUMP HAD BEEN HELPING HIM, BUT THAT HE WAS ON SUCH A HIGH DOSE THAT IT STOPPED HELPING HIS PAIN A FEW MONTHS AGO. THE PATIENT REPORTED THAT HIS HEALTHCARE PROVIDER (HCP) CHANGED HIS MEDICATIONS; HE RECEIVED UP TO 319 MCGS OF FENTANYL. NONETHELESS, HE EXPERIENCED SYMPTOMS OF PAIN IN HIS NECK, HIPS, AND LOW BACK. THE PATIENT ALSO HEARD THE NON-CRITICAL ALARM ON HIS PUMP APPROXIMATELY TWO WEEKS PRIOR. HE HEARD THE CRITICAL ALARM AS WELL, BUT HE HEARD IT FOR THE FIRST TIME ABOUT ONE WEEK AFTER HE HEARD THE NON-CRITICAL ALARM. IT WAS LATER REPORTED THAT THE PATIENT WAS OUT OF MEDICATION AND FOR APPROXIMATELY TWO WEEKS HE HAD GONE THROUGH WITHDRAWAL. THE PATIENT'S FAMILY WANTED THE PUMP TURNED OFF DUE TO THE CONSTANT ALARM. THE PATIENT DID NOT INTEND TO HAVE HIS PUMP REFILLED AS HE WANTED TO "GET THE MEDICATIONS OUT OF HIS SYSTEM." HE DID SEE HCP REGARDING HIS WITHDRAWAL AND PAIN SYMPTOMS, AND HE WENT TO THE EMERGENCY ROOM. THE PATIENT'S FAMILY ALSO REPORTED THAT THE PATIENT WAS DEPRESSED. THE PUMP WAS USED TO DELIVER FENTANYL, BACLOFEN AND MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10530 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention