BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUET EDMS, INTERLINK INJECTION SITES

    MDR report key: 3881396 · Received June 18, 2014

    Report

    Report Number
    2021898-2014-00207
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K983799
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED UNIT WAS PATENT. IT DID NOT MEET REQUIREMENTS FOR THE LEAKAGE TEST DUE TO A DISCONNECTED AND MISSING DRIP CHAMBER STOPCOCK. ADHESIVE WAS OBSERVED IN THE INTERIOR OF THE CONNECTION. IT IS UNKNOWN HOW OR WHEN THE DAMAGE OCCURRED. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED. ADDITIONAL DEVICE INFORMATION: IT WAS LATER DISCOVERED THAT THE ORIGINAL REPORT WAS FOR A DRIP CHAMBER STOPCOCK DISCONNECT, NOT A PATIENT LINE STOPCOCK DISCONNECT. (B)(4)

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE THREE WAY STOPCOCK DISCONNECTED FROM THE PATIENT LINE TUBING. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT IMPACT AND THAT THE DUET WAS REPLACED WITH A NEW UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357985 DUET EDMS, INTERLINK INJECTION SITES SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening