Events

Recall of Device Recall Medtronic SynchroMed EL

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
    46685
  • Event Risk Class
    Class 1
  • Event Number
    Z-1148-2008
  • Event Initiated Date
    2008-01-16
  • Event Date Posted
    2008-03-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67962
  • 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 programmable infusion pump - Product Code LKK
  • Reason
    Device/drug interaction - the company updated the labeling for the devices to include current patient management and treatment recommendations. the company received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. on january 16, 2008, medtronic sent a letter to doctors who implant these d.
  • Action
    An Urgent Medial Device Correction letter was sent January 16, 2008, to Health Care Professionals. The letter describes the incidences, symptoms and recommendations for patient management. Excerpts from the approved Medtronic Professional Labeling are also included with the letter. The firm has requested unreported inflammatory mass in a patient with a Medtroinc device to the firm and to the FDA MedWatch Program by phone at 1-800-FDA-1088. Additional assistance may be obtained by contacting Medtronic Neuromodulation Technical Services at 1-800-707-0933.

Device

Device Recall Medtronic SynchroMed EL
  • Model / Serial
    all serial numbers
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA including states of Washington D.C., Puerto Rico, and countries of Aruba, Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Faroe Islands, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Mexico, Netherlands, Netherlands Antilles, New Caledonia, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City State.
  • Product Description
    Medtronic SynchroMed EL Implantable Infusion Pump, model 8627L-18. The contents of the inner package have been sterilized by ethylene oxide gas. 18 mL pump with reservoir valve, screened side catheter access port and suture loops. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

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