BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1926418 · Received November 11, 2010

    Report

    Report Number
    3004209178-2010-09362
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 27, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO THERAPEUTIC EFFECT FROM THE PUMP. THERE WERE NO COMPLICATIONS NOTED AT THE INITIAL IMPLANT AND GOOD "FLOW" WAS PRESENT IN THE CATHETER AT IMPLANT. THE DELIVERY DOSE WAS INCREASED WITHOUT ANY EFFECT. AN X-RAY REVEALED NO ANOMALIES. THERE WAS A DISCREPANCY NOTED 2-5 MONTHS AFTER THE PUMP WAS IMPLANTED. THE EXPECTED RESIDUAL VOLUME WAS 7 ML AND THE ACTUAL RESIDUAL VOLUME WAS 19.5 ML. A ROLLER STUDY AND A CONTRAST STUDY WERE PLANNED. THE EVENT LOGS WERE REVIEWED AND WERE NORMAL. IT WAS STATED THAT THE PUMP HAD NOT DELIVERED ANY OF THE DRUG INTO THE SPINAL CANAL. THE MEDICATION BEING DELIVERED VIA THE DEVICE WAS LIORESAL. THE PATIENT WAS AT HOME.

    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 CATHETER: MODEL 8709SC, LOT# 0203808852| IMPLANTED:| EXPLANTED: