BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3830700 · Received May 23, 2014

    Report

    Report Number
    3007566237-2014-01429
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 27, 2014
    Report Date
    June 24, 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
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP WAS ALARMING DUE TO EMPTY RESERVOIR THE DAY OF REPORT. IT WAS NOTED THE LOW RESERVOIR ALARM HAD BEEN OCCURRING FOR THE PAST 10 DAYS. IT WAS NOTED THE PATIENT HAD A REFILL ON THE DAY OF REPORT. IT WAS NOTED THE PATIENT HAD TINGLING IN THE FEET. THE PUMP WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION REPORTED THAT EVERYTHING WAS OK, THE PATIENT WAS FINE, AND THERE WERE NO ISSUES. IT WAS STATED THE PATIENT MISSED THEIR REFILL DURING (B)(6) AND DID NOT REALIZE THE LOW RESERVOIR ALARM WAS GOING OFF. IT WAS NOTED THE PUMP HAD ¿STOPPED¿ 20 MINUTES BEFORE THE LOGS WERE CHECKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308534 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1