BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDMS PATIENT CONNECTION LINE ASSEMBLY

    MDR report key: 3971839 · Received July 31, 2014

    Report

    Report Number
    2021898-2014-00275
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 4, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GWM
    PMA / PMN Number
    K984053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE TUBING WAS DISCONNECTED FROM THE CONNECTORS; THEREFORE, THE DEVICE DID NOT MEET THE REQUIREMENTS FOR PATENCY AND LEAK TESTING. IT IS UNKNOWN HOW OR WHEN THE DAMAGE OCCURRED. THERE WERE TOOL MARKS ON THE CONNECTOR INDICATING EXCESSIVE TORQUE. THERE WAS ADHESIVE NOTED ON THE CONNECTOR AS WELL AS THE TUBING. THE CONNECTIONS SHOULD NOT BE TIGHTENED USING SURGICAL TOOLS OR INSTRUMENTS; THEY SHOULD ONLY BE FINGER TIGHTENED; AS OVER TIGHTENING COULD LEAD TO BREAKAGE OR LEAKAGE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT ONE OF THE CONNECTORS ON THE LUMBAR DRAIN WAS SEPARATED. ACCORDING TO THE REPORT, THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446483 EDMS PATIENT CONNECTION LINE ASSEMBLY DEVICE, MONITORING, INTRACRANIAL PRESSURE GWM MEDTRONIC NEUROSURGERY 207166972

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR