BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3802599 · Received May 9, 2014

    Report

    Report Number
    3004209178-2014-08800
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    February 16, 2014
    Report Date
    April 16, 2014
    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
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BREATHING ISSUES WITH DILAUDID TWO MONTHS AGO. IT WAS NOTED THE PATIENT ORIGINALLY HAD FENTANYL AND BUPIVACAINE, BUT THERE WAS A MESS UP AND THE FENTANYL WAS TAKEN OUT OF THE PUMP AND REPLACED WITH DILAUDID. IT WAS NOTED THE DILAUDID DECREASED THE PATIENT¿S BREATHING THAT STARTED AS SOON AS DILAUDID WAS PUT INTO THE PUMP. IT WAS STATED THE DILAUDID WAS REMOVED FROM THE PUMP ON (B)(6) 2014 AND REPLACED WITH FENTANYL AND BUPIVACAINE. IT WAS NOTED THE ISSUE WAS RESOLVED BY REMOVING DILAUDID FROM THE PUMP. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE FOR THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281421 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention