BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRICULAR CATHETER, STANDARD, BIOGLIDE

    MDR report key: 1930699 · Received December 14, 2010

    Report

    Report Number
    2021898-2010-00351
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 16, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K951258
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE VENTRICULAR CATHETER PASSED THE PATENCY CHECK AND SHOWED NO ANOMALIES. THE STERILIZATION RECORDS FOR LOT C60995 INDICATE THAT ALL PROCESSING PARAMETERS WERE WITHIN SPECIFICATIONS AND ALL SAMPLES PASSED QUALITY TESTING. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE PRODUCT CAUTION THAT "LOCAL AND SYSTEMIC INFECTIONS ARE NOT UNCOMMON WITH ANY SHUNTING PROCEDURE". MEDTRONIC NEUROSURGERY HAS RECEIVED NO OTHER COMPLAINTS FOR THIS LOT AND A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEW DAYS AFTER THE SURGERY, THE PT'S SYMPTOMS HAD NOT IMPROVED, AND SUBCUTANEOUS FLUID WAS FOUND BY A CT SCAN. ON (B)(6) 2010, THE PT HAD A REVISION SURGERY AND THE DOCTOR FOUND THE CATHETER WAS INFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRICULAR CATHETER, STANDARD, BIOGLIDE JXG MEDTRONIC NEUROSURGERY NA C60995

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R CATALOG# 93522, LOT# C64800| CATALOG# 42365, LOT# C53173