Events

Recall of NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces Pulse;Response;Neuro

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

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
    63008
  • Event Risk Class
    Class 2
  • Event Number
    Z-2343-2012
  • Event Date Posted
    2012-09-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112304
  • 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
    Stimulator, electrical, evoked response - Product Code GWF
  • Reason
    In january 2010, medtronic issued a recall of medtronic nim 3.0 patient interfaces after medtronic identified a trend of open channel conditions (signal loss from the electrode). when the nim 3.0 detects the signal loss from the electrode (i.E. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu.
  • Action
    The firm, Medtronic USA, Inc., sent an "URGENT Product Recall Notification" letter dated September 27, 2010, to its U.S. and International customers. The letter described the product, problem and actions to be taken. The customers were instructed to verify their receipt of this notice and complete and sign the Product Replacement checklist form indicating that their sales representative has completed the replacement of their devices and fax to 1-651-367-8055. U.S. Customer Units - replacement kits with their contents will be provided to each Area Sales Manager (ASM) for each customer along with documentation of serial number units to be replaced. Each ASM will be responsible for delivering a replacement unit(s) and picking up and returning each of their customer's units using the pre-labeled replacement kit boxes. International Customer Units- International units, depending on the geography will either be replaced or repaired and returned. If replacement is planned, the International Business Manager (IBM) will receive replacement kits as described for the U.S. In those geographies where devices will be repaired and returned, kits with the following contents will be sent to IBM's along with documentation of serial number units to be repaired. Foreign distribution: In the larger territories (i.e. Australia, Japan, Canada, EMEA-Europe, Middle East, Africa), repairs/rework were handled at the Medtronic facilities in those geographic areas. In the smaller geographic areas (Singapore, Thailand, Hong Kong, Korea, Latin America ), where there were limited sales, devices were returned to the U.S. In all cases (large and small geographic areas), devices were returned via a Medtronic entity (sales office or distribution center). If you have any questions regarding the subject Actron or the content of this letter, contact the Distinguished Regulatory Affairs Advisor at 904-279-7532.

Device

NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces Pulse;Response;Neuro
  • Model / Serial
    8253410 (Neuro). All Serial Numbers.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Australia, Austria, Belgium, Canada, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Lebanon, Libya, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudia Arabia, Singapore, Slovak, Spain, SRI Lanka, Sweden, Turkey, United Arab Emirates, and United Kingdom.
  • Product Description
    Interfaces subject to recall: || Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro). || LABELING: || Box Label: REF 8253410 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***" || Top of unit is labeled in part: "***NIM-Response 3.0***Medtronic***" || Bottom/Underside of unit is labeled in part: "***5X20mm FA.L., 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE, FL USA***" || Cord is labeled in part: "***Ref.***Mfg Date***Sn***" || The NIM 3.0 Patient Interfaces [REF #'s 8253210 (Pulse), 8253200 (Response), 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots.
  • Manufacturer
    Medtronic Xomed, Inc.

Manufacturer

Medtronic Xomed, Inc.
  • Manufacturer Address
    Medtronic Xomed, Inc., 6743 Southpoint Dr N, Jacksonville FL 32216-6218
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA