BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA VALVE, SMALL, PERFORMANCE LEVEL 1.5

    MDR report key: 4513378 · Received February 12, 2015

    Report

    Report Number
    2021898-2015-00042
    Event Type
    Injury
    Date Received
    February 12, 2015
    Report Date
    January 13, 2015
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K902783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE, AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. CORRECTION: IT WAS LATER REPORTED TO MEDTRONIC NEUROSURGERY THAT THIS WAS NOT AN EXPLANTED DEVICE. THE INITIAL INFORMATION WAS SENT TO MEDTRONIC NEUROSURGERY TO DETERMINE WARRANTY INFORMATION IN CASE DEVICES ARE EXPLANTED. THE HOSPITAL CONTACT CONFIRMED THAT THIS DEVICE WAS NOT EXPLANTED AND THERE WAS NO COMPLAINT ON THE DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103881 DELTA VALVE, SMALL, PERFORMANCE LEVEL 1.5 SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R