BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2061945 · Received April 5, 2011

    Report

    Report Number
    3004209178-2011-02575
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE. DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE SCRUB TECH AND PHYSICIAN COULD NOT GET BACK FLUID EASILY; THE SUCTION WAS NOT AS TIGHT AS IT USUALLY WAS. THEY TRIED RECONNECTING THE NEEDLE AND USED DIFFERENT SYRINGES; THERE WAS REALLY NOT ANY DIFFERENCE. A BIT OF FLUID CAME OUT, BUT THE PHYSICIAN DID NOT WANT TO IMPLANT IN CASE THE PUMP WAS DEFECTIVE. THE PUMP WAS NOT IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1