BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3895338 · Received June 25, 2014

    Report

    Report Number
    3004209178-2014-12063
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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: 2014 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID NEU_UNKNOWN_PROG; PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVER THE PAST COUPLE OF DAYS, THE PATIENT WAS GETTING LOCKED OUT OF THE PERSONAL THERAPY MANAGER (PTM)'S BOLUSES WHEN THE PATIENT DOES NOT THINK HE SHOULD BE. IT WAS NOTED THAT THE PUMP PATIENT ACTIVATION LOGS SHOWED A COUPLE ENTRIES WHERE THE PATIENT GOT AN 88 CODE ON THE SAME DATE AND TIME AS AN 89 CODE. IT WAS INITIALLY REPORTED THAT THE PATIENT HAD A LOCKOUT INTERVAL OF 4 HOURS BUT WHEN THE PRINTOUTS WERE REVIEWED, THE LOCKOUT WAS 10 MINUTES WITH A DOSE RESTRICTIN INTERVAL (DRI) OF 4 IN 24 HOURS AND A MAXIMUM ACTIVATION OF 4 TIMES. THE PUMP WAS INFUSING FENTANYL, CLONIDINE, BUPIVACAINE, AND MORPHINE. IT WAS NOTED THAT 9 BOLUS REQUESTS HAD BEEN DENIED. IT WAS LATER REPORTED THAT THE BOLUS LOCKOUT WAS CHANGED TO 4 HOURS AS THE PHYSICIAN ACCIDENTALLY SET IT FOR 10 MINUTES TWO DAYS PRIOR TO WHEN THE PATIENT STARTED GETTING LOCKED OUT. THERE WERE NO KNOWN SOURCES OF ELECTROMAGNETIC INTERACTIONS. THE PATIENT REPORTEDLY HAD NOT BEEN SEEN SINCE THE DAY OF THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371625 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR