BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1915538 · Received November 5, 2010

    Report

    Report Number
    3004209178-2010-08973
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 15, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED PAIN RELIEF IN THE LEFT SIDE, BUT NO RELIEF IN THE RIGHT LEG. THE PT STATED THAT A WEEK AFTER IMPLANT, THE PT WAS BLEEDING INTERNALLY AND NOW THE TOP OF THE PUMP WAS "SPONGY AGAIN." THE PT HAD PAIN GOING ACROSS THE BACK AND BELIEVED THAT THE PAIN MIGHT BE FROM EXERTING HIMSELF AND TRYING TO WALK. THE PT HAD A REFILL APPT SCHEDULED WITH THE HEALTH CARE PROVIDER. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE LIORESAL AND MORPHINE. IT WAS NOTED THAT THE MORPHINE CONCENTRATION WAS 10 MG, BUT WAS 5 MG WHEN MIXED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT#: N257190012