BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNERVISION SNAP SHUNT VENT CATH, BG, 5CM

    MDR report key: 1840014 · Received September 10, 2010

    Report

    Report Number
    2021898-2010-00207
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    July 22, 2010
    Report Date
    August 11, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K983331
    Removal / Correction Number
    Z-1124-1152-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE, AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ON FEBRUARY 12, 2009, MEDTRONIC NEUROSURGERY ISSUED A VOLUNTARY RECALL ON ALL BIOGLIDE SNAP SHUNT VENTRICULAR CATHETERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CT SCAN AND A SHUNT SERIES WERE PERFORMED ON (B)(6) MALE PATIENT. THE IMAGING FINDINGS WERE CONSISTENT WITH A DISCONNECTION OF THE PROXIMAL CATHETER. DURING REVISION SURGERY, IT WAS FOUND THAT THE CATHETER WAS NOT CONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNERVISION SNAP SHUNT VENT CATH, BG, 5CM JXG MEDTRONIC NEUROSURGERY NA C02568

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization| R