BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHROMED

    MDR report key: 493815 · Received October 31, 2003

    Report

    Report Number
    2182207-2003-00996
    Event Type
    Other
    Date Received
    October 31, 2003
    Date of Event
    September 23, 2003
    Report Date
    October 22, 2003
    Manufacturer
    NEURO
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HCP REPORTED A PUMP WAS IMPLANTED BEYOND ITS EXPIRATION DATE. THE EXPIRATION DATE ON THE PUMP WAS 09/15/2003 AND THE PUMP WAS IMPLANTED IN 2003. A FOLLOW UP REPORT WILL BE SENT WHEN ADDITIONAL INFORMATION IS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED PUMP LKK NEURO PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other EXPLANTED: UNK.| CATHETER MODEL: UNK, LOT# UNK, IMPLANTED, UNK