BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3160235 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-10063
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    May 14, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NOT RECEIVED PAIN RELIEF FROM THE DEVICE SYSTEM. THE PATIENT STATED THAT SHE HAD 4 FAILED BACK SURGERIES AND HIP SURGERY AND HAD NOT BEEN OUT OF PAIN SINCE. THE PATIENT¿S PUMP WAS REFILLED ON (B)(6) 2012 AT WHICH TIME THE DOSE WAS INCREASED; HOWEVER, THE PATIENT WAS STILL IN PAIN AND NEEDED THE DOSE INCREASED AGAIN AND WOULD NEED THE DOSE INCREASED UNTIL THE RIGHT DOSE WAS REACHED. THE PATIENT WAS SEEKING A CLOSER HEALTHCARE PROVIDER (HCP) TO REFILL THE PUMP AS HER CURRENT HCP WAS TOO FAR AWAY. IT WAS LATER REPORTED THAT THE PATIENT HAD NOT FELT ANY RELIEF AFTER SEVEN MONTHS OF HAVING THE PUMP IMPLANTED, EVEN WHEN THE DOSE WAS INCREASED. THE PATIENT¿S NEUROSURGEON THAT PERFORMED THE IMPLANT INFORMED THE PATIENT THAT HE WOULD HAVE TO RELOCATE THE PUMP BECAUSE ¿IT POPS OUT, ROLLS AROUND, FLIPS OVER ¿ IT DOES ALL KIND OF TRICKS FOR YOU.¿ THE PATIENT STATED THAT DURING A REFILL ONE MONTH PRIOR TO THE REPORT HER PAIN MANAGEMENT DOCTOR HAD TO HAVE SOMEONE HELP FLIP THE PUMP BACK OVER IN ORDER TO PERFORM TELEMETRY AND FILL THE PUMP. THE DOCTOR HAD THE PATIENT UNDER X-RAY DURING THE REFILL AND KEPT HITTING METAL. AFTER THE PUMP WAS FLIPPED BACK OVER IT WAS SUCCESSFULLY FILLED. THE PUMP MOVEMENT BEGAN FOUR TO FIVE MONTHS PRIOR TO THE REPORT. A CT SCAN WAS PERFORMED AND THE NEUROSURGEON WAS TO WORK WITH A PLASTIC SURGEON TO HAVE A LAYER OF FAT REMOVED AND THE PUMP RELOCATED. THE PATIENT INDICATED THAT IT COULD HAVE BEEN THE MORPHINE THAT DID NOT WORK FOR HER AND SHE WAS TO ASK THE DOCTOR TO CHANGE MEDICATIONS WHEN THE PUMP IS RELOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260910 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR