BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNERVISION SNAP SHUNT VENTRICULAR CATHETER, STD

    MDR report key: 2068049 · Received March 30, 2011

    Report

    Report Number
    2021898-2011-00076
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 4, 2011
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GWG
    PMA / PMN Number
    K940096
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A TEAR WAS FOUND IN THE CATHETER WHERE IT CONNECTS TO THE SNAP BASE. IT IS UNKNOWN HOW OR WHEN THIS DAMAGE OCCURRED. THIS DAMAGE PRECLUDED A LEAK CHECK. THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THE PRODUCT CAUTIONS THAT CARE SHOULD BE TAKEN IN HANDLING THE PRODUCT AS SILICONE HAS A LOW CUT AND TEAR RESISTANCE. MEDTRONIC NEUROSURGERY HAS RECEIVED NO PREVIOUS COMPLAINTS FOR LOT C64991, AND A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. COMPONENTS FOR THIS PRODUCT ARE 100% INSPECTED AT TIME OF MANUFACTURE FOR PHYSICAL DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A TEAR WAS FOUND IN THE CATHETER WHERE IT CONNECTS TO THE SNAP BASE. ACCORDING TO THE REPORT THE DOCTOR WAS UNSURE IF IT WAS A PRODUCT DEFECT OR IF HE CUT IT HIMSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNERVISION SNAP SHUNT VENTRICULAR CATHETER, STD GWG MEDTRONIC NEUROSURGERY NA C64991

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK