BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4674099 · Received April 9, 2015

    Report

    Report Number
    3004209178-2015-06279
    Event Type
    Injury
    Date Received
    April 9, 2015
    Report Date
    March 16, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8590-1, LOT# N193634, IMPLANTED: 2009 (B)(6); PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLINICIAN WENT TO DO A REFILL ON A PATIENT AND NOTICED THAT THE PUMP WAS IN MINIMUM RATE MODE. A PRINTOUT SHOWED THAT A RESET OCCURRED AND THE PUMP WAS IN SAFE STATE. THE PUMP WAS PROGRAMMED BACK TO THE DESIRED DOSE. THE PATIENT WAS GOING TO GO BACK IN AFTER A FEW DAYS AND READ THE LOGS. IT WAS NOTED THAT THE PATIENT HAD SOME MEDICAL PROCEDURES INCLUDING A COMPUTED TOMOGRAPHY (CT) SCAN AND A BRONCHOSCOPY AND THEY WERE WONDERING IF PERHAPS ONE OF THOSE MAY HAVE CAUSED THE RESET. THE PATIENT DID NOT HAVE ANY WITHDRAWAL-TYPE SYMPTOMS BUT HAD A SLIGHT INCREASE IN PAIN. THE PUMP WAS INFUSING DILAUDID (HYDROMORPHONE). ADDITIONAL INFORMATION RECEIVED REPORTED THE RESET WAS FOR A LOW-BATTERY. THE SAFE RATE WAS OBSERVED AFTER INTERROGATING THE PUMP. THE SAFE RATE DID NOT OCCUR WHILE A FLEX BOLUS WAS IN USE. IT WAS UNKNOWN IF THERE WAS ANY ELECTRO-MAGNETIC INTERFERENCE (EMI) ASSOCIATED WITH THE SAFE RATE. THE PATIENT HAD A BRONCHOSCOPY IN JANUARY AND THE LOGS SHOWED A RESET IN FEBRUARY. THE PATIENT WAS DOING VERY WELL AND WAS RECEIVING EFFECTIVE THERAPY. THE PROCESS FOR A PUMP REPLACEMENT HAS BEEN INITIATED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF MORE INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234286 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention