BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4055835 · Received September 3, 2014

    Report

    Report Number
    3004209178-2014-16305
    Event Type
    Malfunction
    Date Received
    September 3, 2014
    Report Date
    August 8, 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
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: REVIEWED AND CONFIRMED / UPDATED. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8590-1, LOT# N171755, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY; PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER; PRODUCT ID NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ISSUES WITH HIS PERSONAL THERAPY MANAGER (PTM), BEGINNING ON (B)(6) 2014. THE PATIENT WAS GETTING LOCKED OUT WHEN REQUESTING BOLUSES. LOCKOUTS OCCURRED ON (B)(6) 2014. ON (B)(6) 2014 AT 1:34PM, THE PTM DISPLAYED A LOCKOUT TIME OF 4 HOURS, BUT THE PATIENT HAD NOT REQUESTED A BOLUS SINCE AROUND 5AM. THE PATIENT¿S LOCKOUT INTERVAL WAS 4 HOURS AND HE WAS ALLOWED 6 BOLUSES PER DAY. THE PATIENT WAS GIVEN AN ANTENNA AND CURRENTLY USED IT WITH HIS PTM. THE PUMP LOGS WERE PULLED WHEN THE PATIENT WAS IN THE HEALTHCARE PROVIDER¿S (HCP) OFFICE. THE PATIENT WAS NOT NEAR ANY ELECTROMAGNETIC INTERFERENCE (EMI) WHEN HE USED THE PTM. THE PATIENT DID NOT MOVE THE ANTENNA WHEN REQUESTING BOLUSES. THE PATIENT DID NOT FEEL LIKE HE WAS GETTING A BOLUS WHEN HE WAS LOCKED OUT. SOMETIMES THE PTM MADE THE PATIENT ¿FEEL LIKE HEAVEN¿ AND OTHER TIMES HE COULD NOT FEEL IT. (THIS SOURCE DOCUMENT CONTAINED OMITTED INFORMATION, UNRELATED TO THIS EVENT, WHICH IS CAPTURED IN PES 700342189 AND ADDITIONAL REQUESTED PE) ADDITIONAL INFORMATION RECEIVED REPORTED THE ERROR CODE ¿617¿ WAS ENCOUNTERED ON THE PERSONAL THERAPY MANAGER (PTM). THE PATIENT WAS SCHEDULED TO BE SEEN IN THE OFFICE ON (B)(6) 2014. DIAGNOSTIC TESTING WAS NOT PERFORMED, BUT WAS PLANNED TO BE PERFORMED IN THE FUTURE. THE SYSTEM WAS BEING USED TO DELIVER MORPHINE. THERE WERE NO SYMPTOMS OR COMPLICATIONS AND THE PATIENT STATUS AT THE TIME OF THE REPORT WAS LISTED AS ¿ALIVE ¿ NO INJURY.¿ IT WAS LATER REPORTED THAT THE PATIENT WAS USING THE PTM INCORRECTLY. THE PATIENT WAS REEDUCATED. IT WAS LATER REPORTED THE PTM WAS OCCASIONALLY DISPLAYING A CODE. WHEN THIS CODE WAS DISPLAYED, THE PUMP REPORTEDLY KEPT SHUTTING DOWN AND LOCKED THE PATIENT OUT FOR EXACTLY 4 HOURS. THIS WAS QUITE RARE AND SOMETIMES IT WAS 12 HOURS BEFORE THE PATIENT REQUESTED ANOTHER BOLUS AND THE SAME THING OCCURRED. IT WAS NOTED THAT THE PATIENT WAS ALLOWED A BOLUS EVERY ONCE EVERY 4 HOURS AND 6 TIMES PER DAY. THE PATIENT SPOKE TO A MANUFACTURER REPRESENTATIVE ABOUT THIS ISSUE, WHO WASN¿T ABLE TO PROVIDE AN EXPLANATION FOR THE ISSUE. WITHIN A YEAR OF THE PUMP BEING IMPLANTED, THIS ISSUE BEGAN. IT WAS NOTED THAT THE PATIENT HAD BEEN ABLE TO FLUCTUATE HOW MANY BOLUSES HE NEEDED BECAUSE OF THE SEVERITY OF HIS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536599 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR