Events

NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces Pulse;Response;Neuro 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Xomed, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    63008
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2343-2012
  • 사례 출판 날짜
    2012-09-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-11-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112304
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Stimulator, electrical, evoked response - Product Code GWF
  • 원인
    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.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    8253410 (Neuro). All Serial Numbers.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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.
  • 제조사 주소
    Medtronic Xomed, Inc., 6743 Southpoint Dr N, Jacksonville FL 32216-6218
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “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