BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2499328 · Received March 22, 2012

    Report

    Report Number
    3004209178-2012-01755
    Event Type
    Malfunction
    Date Received
    March 22, 2012
    Report Date
    February 28, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL # 8709SC LOT # N227238009 IMPLANTED ON: (B)(6) 2009 EXPLANTED ON: UNKNOWN.(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS TO HAVE AN MRI BUT WAS UNABLE TO TOLERATE THE PROCEDURE. THE PUMP WAS INTERROGATED. THE PUMP HAD STALLED AND RECOVERED EVERY DAY AS FAR BACK AS THE EVENT LOGS GO ((B)(6) 2012). IT WAS UNCLEAR IF THE LAST STALL RECOVERED WITHIN 2 HOURS. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC. THE CAUSE OF THE STALLS/RECOVERIES WAS UNKNOWN. IT WAS NOTED THAT THE PATIENT WAS IN A MOTORIZED WHEELCHAIR. DEVICE TROUBLESHOOTING WAS BEING CONSIDERED. THE PUMP DELIVERED HYDROMORPHONE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1