BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3231901 · Received July 17, 2013

    Report

    Report Number
    3004209178-2013-11899
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 25, 2013
    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
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8590-1, LOT# N238367, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING THE DEVICE/THERAPY BUT WAS WORKING WITH THE DOCTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS NOT WORKING AND THE PATIENT WAS IN PAIN. IF THE PATIENT WAS SITTING THE PAIN WAS BEARABLE AND IF THE PATIENT WAS MOVING OR TRYING TO GET UP IT WAS UNBEARABLE. THE PAIN HAD BEEN OCCURRING GRADUALLY OVER THE LAST SEVERAL MONTHS. THE PATIENT HIT THE PUMP ON A CHAIR ABOUT 2-3 MONTHS AGO. AN MRI WAS PERFORMED ABOUT A MONTH AGO BUT THE RESULTS WERE UNKNOWN TO THE PATIENT. IT WAS NOTED THAT THE PATIENT HAD BOTH A REFILL MANAGING PHYSICIAN AND A PRIMARY CARE PHYSICIAN (PCP) HOWEVER, THE PATIENT DID NOT FEEL THAT THE PCP WANTED TO PRESCRIBE ANYTHING. IT WAS BELIEVED THAT THE PUMP CONTAINED A PAIN MEDICATION AND A 'MUSCLE RELAXER.'

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT WAS THINKING ABOUT GETTING THE PUMP REMOVED. THE PATIENT DID NOT FEEL THAT THE PUMP WAS DOING ANY GOOD AND HADN'T BEEN WORKING THE LAST FEW WEEKS. THE PATIENT FELT THAT THE PUMP WAS CAUSING MORE PAIN THAN GOOD BECAUSE IT SITS ON THE RIGHT HIP AND WAS CAUSING HIP PAIN. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332266 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR