BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2992140 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-03422
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT'S SWELLING WENT DOWN AFTER IMPLANT, THE PUMP STARTED FLIPPING BACK AND FORTH. THE PATIENT NOTED SHE FLIPPED IT ON HER OWN TO BE ABLE TO USE HER PERSONAL THERAPY MANAGER (PTM). THE PATIENT NOTED HER PHYSICIAN RECOMMENDED AN ABDOMINAL BINDER, AND SHE WAS SCHEDULED FOR A FOLLOW-UP APPOINTMENT IN THE FUTURE. THE PUMP WAS BEING USED TO DELIVER FENTANYL. IT WAS ADDITIONALLY NOTED BY THE PATIENT'S CLINIC THAT THERE WAS NO MENTION OF THE PATIENT HAVING A FLIPPED PUMP IN THE CHART. THE SWELLING WAS NOTED AS NORMAL AS THE PATIENT HAD JUST HAD SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98055 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1