BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1213075 · Received October 23, 2008

    Report

    Report Number
    3004209178-2008-06811
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP HAD MORE VOLUME THAN EXPECTED. THE VOLUME DISCREPANCY WAS GREATER THAN THE MANUFACTURER'S SPECIFICATIONS. THE ESTIMATED RESIDUAL VOLUME WAS 2ML WHILE THE ACTUAL RESIDUAL VOLUME WAS 40ML. TROUBLESHOOTING WAS BEING CONSIDERED. NO PATIENT SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR CATHETER: MODEL 8709SC| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8840