Events

Recall of 8709SC: Indura 1P

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Neuromodulation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    48616
  • Event Risk Class
    Class 2
  • Event Number
    Z-2173-2008
  • Event Initiated Date
    2008-04-14
  • Event Date Posted
    2008-08-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71793
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Implanted Infusion Pump - Product Code LKK
  • Reason
    The sc catheters cannot completely engage with the model 700-04m portal connector. the result of this condition is a possible leakage or disconnect of the sc catheter from the portal during the continuous therapy trial period.
  • Action
    Medtronic informed all Belgium implanting and managing physicians of the SynchroMed II infusion system. Each customer was mailed a Dear Healthcare Professional letter (Medtronic Urgent: Field Safety Notice) on 4/3/08 providing important safety information and patient management recommendations regarding the device incompatibility. The firm recommends that healthcare professionals do not use SC catheters if a connection with an implantable access port is required. Also, if a continuous infusion trial is required with use of an implantable access port, they should use a model 8711 intrathecal catheter. The firm states that for patients who are currently undergoing a continuous trial with an implantable port, replacing the catheter connector before connecting to the SynchroMedd II using the Medtronic model 8578 revision kit is recommended. Medtronic also recommends discussing the risks of connection failure with patients. Local field reps will personally follow-up with affected customers to confirm and document notification.

Device

8709SC: Indura 1P
  • Model / Serial
    All lots numbers included
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    International Distribution --- country of Belgium.
  • Product Description
    Model 8709SC Indura 1P || One-Piece Intrathecal Catheter || Medtronic Inc., Minneapolis, MN 55432 || A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy.
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • Manufacturer Address
    Medtronic Neuromodulation, 800 53rd Ave NE, PO Box 1250, Minneapolis MN 55440-1250
  • Source
    USFDA