BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4110621 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17556
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    September 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A LOW RESERVOIR ALARM OCCURRED. THE PATIENT WENT IN FOR A REFILL A COUPLE OF WEEKS AGO ( DATE UNKNOWN) AND THE HCP TRIED SEVERAL TIMES TO ACCESS THE RESERVOIR PORT BUT WAS UNABLE TO. THE HCP SUSPECTED A FLIPPED PUMP. THE FILLING DIFFICULTY WAS DUE TO THE PUMP FLIPPING IN THE POCKET AND THIS WAS CONFIRMED. HE SCHEDULED THE PATIENT FOR A POCKET REVISION ON (B)(6) 2014. THAT WAS THE EARLIEST THE HCP COULD DO IT BECAUSE HE WAS OUT OF TOWN ALL LAST WEEK. THE HCP OPENED UP THE POCKET, RE-FLIPPED THE PUMP BACK TO PROPER ORIENTATION WITH RESERVOIR FACING UP AND SUTURED IT DOWN AND REFILLED THE PUMP AT THAT TIME. ON (B)(6) 2014 IT WAS REPORTED THE PATIENT HAD AN INCREASE IN PAIN SYMPTOMS PRIOR TO THE POCKET REVISION AND REFILL. AFTER THE HCP RE-FLIPPED THE PUMP AND SUTURED IT DOWN, HE WAS ABLE TO REFILL IT AND START THE PATIENT BACK ON THERAPY. THE REPORTER HAD NOT SEEN OR HEARD ANY MORE ABOUT THE PATIENT¿S STATUS BUT THOUGHT THE PATIENT WAS DOING BETTER SINCE SHE GOT HER REFILL. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS NOTED AS ALIVE, NO INJURY. NO PATIENT OUTCOME WAS REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THE INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE PUMP WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590070 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention