BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3973681 · Received August 1, 2014

    Report

    Report Number
    3007566237-2014-02159
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 7, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID NEU_PTM_PROG, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WENT IN FOR A REFILL IMMEDIATELY AND WAS DOING FINE. THE DRUG INFORMATION WAS NOT KNOWN. THE DEVICE MANUFACTURER REPRESENTATIVE BELIEVED THE RESERVOIR VOLUME WAS SET TO 0.1ML RATHER THAN ¿THE NORMAL¿ 2.0ML LOW RESERVOIR ALARM SO SHE WENT TO ¿ALMOST GOING INTO WITHDRAWAL¿ BUT THEY CAUGHT IT IN TIME THANKS TO THE CODE ON THE PERSONAL THERAPY MANAGER (PTM). NO FURTHER INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS NOT FEELING "GOOD" AND WAS "OUT OF IT". THE PATIENT REPORTED TO THE MANUFACTURER REPRESENTATIVE THEY WERE GETTING AN 8286 ALARM. THE MEDICATION IN THE PUMP WAS UNKNOWN. IT WAS NOTED THE PATIENT HAD THEIR PUMP REPLACED LAST MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449713 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1