BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 1702867 · Received May 26, 2010

    Report

    Report Number
    MW5016132
    Event Type
    Injury
    Date Received
    May 26, 2010
    Date of Event
    May 7, 2010
    Report Date
    May 15, 2010
    Manufacturer
    MEDTRONIC NEUROLOGIC TECHNOLOGIES
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD A HISTORY OF HYDROCEPHALUS SINCE AGE (B) (6). HE HAD SURGERY ON (B) (6) 2010, FOR PLACEMENT OF A MEDTRONIC VP SHUNT. THE PT WAS READMITTED AND TAKEN TO SURGERY ON (B) (6) 2010, BECAUSE THE VP SHUNT WAS MALFUNCTIONING. DURING THE SURGERY OF (B) (6) 2010, THE SURGEON NOTICED THE SHUNT HAD BROKEN AT THE VALVE SITE. SURGEON REPORTED THAT THE SHUNT WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC CE-CONNECTOR VENTRICULOSTOMY OR VP SHUNT CE-RESERVOIR JXG MEDTRONIC NEUROLOGIC TECHNOLOGIES 31237 C52657

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention