BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4221616 · Received November 3, 2014

    Report

    Report Number
    3004209178-2014-20872
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 10, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(4) 2008, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS THAT STARTED ON (B)(6) 2014. THE PATIENT HAD LOSS OF APPETITE, ABDOMINAL PAIN, DIARRHEA, SWEATS, SPASMS AND NAUSEA. THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2014 AND THE PATIENT WAS TREATED FOR THE WITHDRAWAL SYMPTOMS. AN ALARM WAS HEARD; TELEMETRY DID NOT CONFIRM THE ALARM. THE PUMP WAS BEEPING EVERY NOW AND THEN, THREE SINGLE BEEPS, AND HAD BEEN OCCURRING FOR THE PAST FEW DAYS. THE PLAN WAS TO HAVE THE PUMP CHECKED AT THE PHYSICIAN¿S OFFICE ON (B)(6) 2014. THE PUMP WAS LAST FILLED ON (B)(6) 2014. THE PHYSICIAN HAD BEEN CUTTING THE DRUG IN THE PUMP BACK. THE PATIENT MISSED A REFILL AND AN EMPTY RESERVOIR OCCURRED. A STOPPED PUMP OCCURRED AND WAS NOT MORE THAN 48 HOURS. THE SAFE RATE/STATE WAS IN USE. THERE WAS NO PUMP RESET MESSAGE PRIOR TO THE SAFE RATE. IT WAS REPORTED THE ALARM DID NOT OCCUR AFTER A MOTOR STALL HOWEVER IT ALSO NOTED THAT THERE WAS NOT MORE THAN ONE MOTOR STALL IN THE EVENT LOGS. IT WAS UNCLEAR IF A MOTOR STALL OCCURRED. THERE WAS NO ELECTROMAGNETIC INTERFERENCE OR MRI ASSOCIATED TO THE SAFE RATE. THE PUMP WAS REFILLED ON (B)(6)2014. THE PATIENT WAS FEELING BETTER WITH NO MORE SIGNS AND SYMPTOMS OF WITHDRAWAL. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE PUMP WAS DELIVERING MORPHINE 20.0 MG PER ML; DOSE 2.997 MG PER DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION CLARIFIED THAT THE PATIENT NEVER EXPERIENCED A MOTOR STALL. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702261 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR