BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DUET EDMS

    MDR report key: 3894508 · Received June 25, 2014

    Report

    Report Number
    2021898-2014-00215
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED. THE CATALOG NUMBER WAS NOT REPORTED. RECALL NUMBERS Z-1920-2014, Z-1921-2014, Z-1922-2014, Z-1923-2014, Z-1924-2014, WERE ISSUED FOR ALL DUET CATALOG NUMBERS. (B)(4).

    Additional Manufacturer Narrative · 1

    THE RETURNED UNIT WAS PATENT. IT DID NOT MEET REQUIREMENT FOR THE LEAKAGE TEST. THE PROXIMAL PATIENT LINE TUBING WAS DISCONNECTED FROM THE PATIENT LINE STOPCOCK. THE TUBING¿S END APPEARED TO HAVE BEEN CUT. ADHESIVE WAS OBSERVED IN THE INTERIOR OF THE TUBING TO LUER CONNECTION, AS WELL AS ON THE TUBING. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED. THE CATALOG NUMBER WAS NOT REPORTED. RECALL NUMBERS Z-1920-2014, Z-1921-2014, Z-1922-2014, Z-1923-2014, Z-1924-2014 WERE ISSUED FOR ALL DUET CATALOG NUMBERS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT LINE TUBING DISCONNECTED ON A DUET EDMS. THE EXACT EVENT DATE WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371847 UNKNOWN DUET EDMS SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1