BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1934519 · Received November 23, 2010

    Report

    Report Number
    3004209178-2010-09888
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 18, 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
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THEY WERE HAVING DIFFICULTY DURING THE PUMP REFILL PROCEDURE. THEY WERE ABLE TO ASPIRATE THE RESERVOIR, BUT UNABLE TO FILL IT. THEY ASPIRATED WHAT WAS EXPECTED FROM THE PUMP AND THINGS WERE GOING WELL WHILE REFILLING THE PUMP UNTIL THEY HAD 10 ML LEFT. THE LAST 10 ML WOULD NOT GO INTO THE PUMP RESERVOIR. THE NEXT DAY, A PUMP VOLUME DISCREPANCY WAS REPORTED. THE ACTUAL RESIDUAL VOLUME (28 CC) WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME (15.6 CC). THE PT WAS EXPERIENCING INCREASED PAIN. A ROLLER STUDY AND CATHETER DYE STUDY WERE DONE AND NO ISSUES WERE FOUND. AN MRI WAS PLANNED TO DETERMINE IF THE PT HAD A GRANULOMA. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8596SC, LOT# N233737003| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N232986| CATHETER: MODEL 8703W, LOT# L37094| IMPLANTED:| IMPLANTED: