BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3863578 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11263
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    June 5, 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)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD INCREASED PAIN AND NOT BEING ABLE TO TAKE A BATH. THE PATIENT ALSO WAS SUFFERING FROM SEVERE ANXIETY. THE PATIENT WAS HAVING ¿HORRIBLE PROBLEMS¿ AND ¿CANNOT WALK¿. THE PATIENT WAS SCHEDULED FOR A REFILL ON (B)(6) 2012. IT WAS NOTED THE PATIENT WAS DISSATISFIED WITH HER HEALTH CARE PROVIDER (HCP) AND WAS LOOKING FOR A NEW ONE. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE AND ¿OTHER¿. IT WAS FURTHER REPORTED THAT THE PATIENT WENT IN FOR A REFILL ON (B)(6) 2012; HOWEVER, THEY DIDN¿T REFILL THE PATIENT BECAUSE SHE HAS HAVING A SEVERE PANIC ATTACK. SHE WAS DIRECTED TO CALL IN A COUPLE OF WEEKS TO HAVE THE PUMP FILLED. THE PATIENT WAS CURRENTLY FEELING FINE AND WAS NOT HEARING ANY ALARMS. THE PATIENT WAS ¿JUST¿ HAVING A SEVERE PANIC ATTACK AND WAS DEPRESSED, BUT WOULD CALL 911 IF NEEDED. IT WAS ALSO NOTED THE PATIENT¿S SON WAS LIVING WITH HER FOR ASSISTANCE AS WELL. IT WAS LATER REPORTED THAT AN ALARM WAS HEARD; HOWEVER, TELEMETRY DID NOT CONFIRM AN ALARM HOWEVER IT WAS UNCLEAR IF TELEMETRY HAD YET TO BE PERFORMED AT THE TIME OF REPORT AS THE PATIENT HAD YET TO BE SEEN. IT REPORTEDLY SOUNDED LIKE A CRITICAL ALARM WAS SOUNDING AS OF (B)(6) 2012. THE PATIENT¿S SYMPTOMS ALSO SEEMED TO BE RETURNING. THE HCP HAD FIRED THE ¿REFILL HCP¿ FROM HIS CLINIC AND HAD NOT PROVIDED WHAT STEPS FOR THE PATIENT TO TAKE REGARDING REFILLING HER PUMP. IT WAS REPORTED AS OF (B)(6) 2012, THE PATIENT HAD BEEN FREEZING ALL DAY. THE PATIENT WOULD REPORTEDLY BE GOING TO THE ER (EMERGENCY ROOM) AND REQUESTED THAT A DEVICE MANUFACTURER REPRESENTATIVE NOT BE CONTACTED BECAUSE HER HCP ADVISED HER HE WOULD BE CONTACTING A REPRESENTATIVE. IT WAS LATER REPORTED THAT THE PATIENT¿S PUMP ONCE WAS ¿ALMOST DRY¿ AND SHE HAD TROUBLE FINDING ANY HELP. THE PUMP WAS ALARMING CONSTANTLY. THIS WAS BEFORE SHE WAS UNDER HER CURRENT HCP¿S CARE. IT WAS NOTED THIS OCCURRED TWO TO THREE YEARS PRIOR IN REFERENCE TO THE DATE OF THIS REPORT. THE PATIENT¿S OLD MEDICATIONS INCLUDED CLONIDINE, BACLOFEN, ¿UNKNOWN¿ AND MORPHINE. IT WAS UNCLEAR WHAT MEDICATIONS WERE IN THE PUMP AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337803 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1