BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3881879 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-11768
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Report Date
    May 28, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT HAD HIS PUMP TURNED OFF AND DRAINED 6 MONTHS PRIOR TO THIS REPORT. THE REPORTER ASKED WHAT THE LONGEVITY OF THE PUMP WAS. AT THE TIME OF THIS REPORT, THE PATIENT¿S BACK WAS STILL BOTHERING HIM AND HAD BEEN SINCE IMPLANT. THE REPORTER DIDN¿T THINK THAT IT WAS PUT IN THE RIGHT PLACE BECAUSE A MANUFACTURER REPRESENTATIVE WAS PRESENT AT THE APPOINTMENT WHEN THE PUMP WAS TURNED OFF AND STATED THAT IT MAY HAVE WORKED FOR THE PATIENT IF THE ¿LINE¿ WAS MOVED UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE PUMP SHUT OFF ON (B)(6) 2014 BECAUSE HE DIDN¿T THINK IT WAS WORKING. AFTER THE PUMP WAS SHUT OFF, THE PATIENT WENT THROUGH ¿A LITTLE BIT OF WITHDRAWAL.¿ TWO DAYS LATER, THE PATIENT STARTED HEARING A CRITICAL TWO-TONE ALARM. THE PATIENT HEARD IT EVERY HOUR. TELEMETRY HAD NOT YET BEEN PERFORMED. THE PUMP WAS PREVIOUSLY USED TO DELIVER MORPHINE. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED BACK PAIN. THE PATIENT ¿JUST DOES NOT LIKE THE PUMP, EVEN IF IT WAS WORKING.¿ THE PATIENT REQUESTED THAT THE HEALTHCARE PROVIDER (HCP) TURN THE PUMP OFF. IT STARTED TO BEEP AFTER THE PUMP WAS TURNED OFF AND THE PATIENT HAD SOME MILD WITHDRAWAL. THE PATIENT WAS GIVEN MSCONTIN 60MG THREE TIMES PER DAY TO PREVENT WITHDRAWAL. IT WAS INDICATED THAT THE PUMP WAS NOT PERMANENTLY SHUT OFF WITH THE PASSWORD PROVIDED FROM THE MANUFACTURER. AT THE TIME OF THIS REPORT, THE PATIENT WAS FINE AND HAD RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357210 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR