BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4210580 · Received October 29, 2014

    Report

    Report Number
    3004209178-2014-20603
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    October 6, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE THE PATIENT HAD THE PUMP, SHE HAD ¿PROBLEM AFTER PROBLEM WITH IT¿. THE PATIENT HAD BEEN SEEING HER DOCTOR AND WHEN HE REFILLED THE PUMP, THERE WAS MORE MEDICATION THAN THERE WAS SUPPOSED TO BE. THE PATIENT WAS STILL HAVING A LOT OF PAIN AND THE DOCTOR HAD PUT THE PATIENT BACK ON ORAL PAIN MEDICATIONS. EVERYTHING WAS OK WITH THE PUMP FOR ¿ABOUT A MONTH OR SO BUT IT WASN¿T DOING WHAT IT WAS SUPPOSED TO¿. WHEN THE PATIENT WOULD USE THE PERSONAL THERAPY MANAGER (PTM) SHE WOULD STILL HAVE THE PAIN. THE PATIENT HAD EXTREME PAIN AND THE PUMP SITE AND THE PUMP WAS ¿MOVING AROUND¿. THE PUMP WAS IN THE PATIENT¿S LEFT BUTTOCK AND IT WAS EXTREMELY PAINFUL. THE PUMP WOULD MOVE AND BULGE OUT AND IT HAD FLIPPED A FEW TIMES. IT WAS SO PAINFUL THAT THE PATIENT COULD NOT SIT ON THAT SIDE OR EVEN TOUCH IT. THE PATIENT QUESTIONED IF THE PUMP COULD BE REMOVED AND RE-IMPLANTED IN A DIFFERENT AREA. THE PUMP SEEMED TO BE WORKING LESS AND LESS. PATIENT OUTCOME WAS NOT PROVIDED. THE DEVICE SYSTEM DELIVERED FENTANYL AND BUPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED A PATIENT HAD A RETURN OF SYMPTOMS OVER THE WEEKEND OF (B)(6) 2014. THE PATIENT WAS "HURTING REALLY BAD". IT FELT LIKE THE PUMP WASN¿T WORKING, SO THE PATIENT SAW HER HEALTH CARE PROVIDER (HCP) ON (B)(6) 2014, AND THEY INCREASED HER DOSE AND SHE ALSO RECEIVED HER OTHER PRESCRIPTIONS. NO INTERVENTIONS OR OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN MORE INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691395 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR