Events

Recall of Device Recall Medtronic SynchroMed EL Programmable Infusion Pump

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
    49603
  • Event Risk Class
    Class 2
  • Event Number
    Z-0583-2009
  • Event Initiated Date
    2008-08-25
  • Event Date Posted
    2009-01-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73903
  • 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
    Pump, infusion, implanted, programmable - Product Code LKK
  • Reason
    Medtronic issued a letter to healthcare professionals providing important safety information regarding mri (magnetic resonance imaging) effects on synchromed el and synchromed ii implantable infusion pumps. as stated in product labeling, the magnetic field of an mri will temporarily stop the rotor of the pump motor and suspend drug infusion for the duration of mri exposure for all synchromed pump.
  • Action
    An Urgent Medical Device Correction, Important Information on Potential MRI Effects letter, dated August 2008, was sent to health care professionals beginning August 25, 2008. The letter described the issue, provided patient management recommendations and included enclosures: Roller Study Procedure to confirm pump function, Post MRI Pump Interrogation Guidelines and New Information Regarding Potential MRI Effects.

Device

Device Recall Medtronic SynchroMed EL Programmable Infusion Pump
  • Model / Serial
    All SynchroMed EL and SynchroMed II pumps.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution --- USA including Washington D.C., and Puerto Rico, and countries of Algeria, Aruba, Austria, Belarus, Belgium, Croatia, Cyprus Czech Republic, Denmark, Egypt, Finland, France, French Polynesia, Germany, Greece, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy , Jordan Kuwait, Lebanon, Luxembourg, Malta, Netherlands, Netherlands Antilles, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia and Montenegro, Slovakia, Slovenia, Sough Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City State, New Caledonia, Brazil, Dominican Republic, Mexico, Hong Kong, Singapore, Canada, Australia and Japan.
  • Product Description
    Medtronic SynchroMed EL Programmable Pump, Model 8626-10. 10 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. 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. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA. || The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids.
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

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