BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3110011 · Received May 13, 2013

    Report

    Report Number
    2182208-2013-00497
    Event Type
    Injury
    Date Received
    May 13, 2013
    Report Date
    April 5, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8703, LOT # J92-103102, IMPLANTED: (B)(6) 1992, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS FILED ON DEVICE WITH SERIAL NUMBER (B)(4) WITH MODEL 8611H. ADDITIONAL REVIEW INDICATED THE CORRECT PUMP SERIAL NUMBER WAS (B)(4) WITH MODEL 8637-40. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT WAS DUE TO EXTENSIVE SPINE FUSION SURGERY ON (B)(6) 2012. THE PATIENT HAD SPINE FUSION (POSTERIOR T4-5) AND THE CATHETER DISLODGED DURING THE SURGERY. THE PUMP AND CATHETER WERE SUBSEQUENTLY REMOVED. THE PATIENT EXPERIENCED INADEQUATE PAIN CONTROL. NO HOSPITALIZATION WAS REQUIRED. THE PATIENT OUTCOME WAS NOTED AS NO INJURY. THE PUMP WAS BEING USED TO DELIVER MORPHINE, CLONIDINE, AND BUPIVACAINE.

    Description of Event or Problem · 1

    A PROBLEM WAS REPORTED. PATIENT REPORTED CATHETER CAME OUT INTO THE EPIDURAL SPACE TWO YEARS AFTER IMPLANT AND THE HEALTH CARE PROFESSIONAL (HCP) HAD TO FIX IT. PATIENT REPORTED HER PAIN SPECIALIST THOUGHT SOMETHING HAPPENED TO THE CATHETER BECAUSE OF PATIENT¿S NEW SYMPTOMS AND WHEN HCP TRIED TO ASPIRATE SPINAL FLUID THEY COULD GET A SAMPLE. PATIENT¿S ¿NEW SYMPTOMS¿ WERE NOT SPECIFIED. THE HCP WANTED THE PATIENT TO STOP USING THE PUMP AND START USING ORAL MEDICATION (MORPHINE) BUT PATIENT WAS SCARED ABOUT STOPPING THE PUMP AND DO ORAL MORPHINE. HCP IS CONCERNED ABOUT GRANULOMAS FORMING WITH THE PUMP. A FOLLOW UP WAS REQUESTED BUT NO ADDITIONAL INFORMATION WAS RECEIVED AS OF THE TIME OF THIS REPORT. A REPORT WILL BE PROVIDED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211143 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention