Device Recall Cyberonics 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cyberonics, 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
    59139
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0005-2012
  • 사례 시작날짜
    2011-05-06
  • 사례 출판 날짜
    2011-10-04
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-12-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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, autonomic nerve, implanted for epilepsy - Product Code LYJ
  • 원인
    An investigation was initiated based on a report from the field in which an intensive follow-up indicator (ifi) message was unexpectedly received by a medical professional when using model 250 version 8.0 software to interrogate a patient's model 103 generator.
  • 조치
    The firm, Cyberonics Inc., initiated containment actions on March 17, 2011 to prevent additional affected devices from being shipped. The firm initiated contact with implanting facilities in the United States on May 6, 2011 and international facilities and distributors on May 10, 2011 to remove product from the field that has not yet been implanted. Additionally, a "Field Safety Alert" letter was sent to all affected medical professionals. The letter identifies the affected product, the issue, and the action(s) to be taken by the physicians. Consignees are instructed to complete and return an attached Effectiveness Check Form. If assistance is needed physicians may contact Clinical Technical Support at 866-882-8804 or via email at clinicaltechnicalservices@cyberonics.com

Device

  • 모델명 / 제조번호(시리얼번호)
    Serial #'s: 2181, 3427, 3902, 4082, 4083, 4116, 4129, 4132, 4158, 4177, 4185, 4204, 4235, 4304, 4351, 4495, 4591, 4610, 4621, 4716, 4728, 4737, 4823, 4834, 4855, 4904, 5105, 5165, 5220, 6039, 6046, 6121, 6124, 6234, 6343, 6513, 6552, 6625, 6674, 6680, 6682, 6700, 6715, 7662, 7738, 7875, 8008, 8163,8820, 8971, 9010, 9171, 9213, 9215, 9217, 9222, 9241, 9260, 9283, 9312, 9333, 9398, 9442, 9451, 9547, 9552, 12590, 12672, 18644, 21949, 22061, 22177, 22455, 22814, 23267, 23736, 25079, 25125, 25545, 25888, 26212, 26254, 26346, 26513, 26527, 26847, 26912, 26932, 27012, 27026, 27127, and 32232.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, CO, FL, GA, ID, IL, KS, OH, AR, MA, MI, MN, MO, NC, NH, NJ, NM, NY, OH, OR, PA, TN, TX, UT, WA, WI and WV. Products were also distributed to WASHINGTON DC and Puerto Rico and the countries of: Austria, Belgium, Finland, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, and United Kingdom.
  • 제품 설명
    VNS Therapy Demipulse Model 103 Generator Cyberonics, Inc. Houston, Texas, Model 103 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may be found at http://us.cyberonics.com/en/vns-therapy-for-epilepsy/healthcare-professionals/vns-therapy/manuals-page. || Product Usage: The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures, which are refractory to antiepileptic medications and for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Cyberonics, Inc, 100 Cyberonics Blvd, Houston TX 77058-2069
  • 제조사 모회사 (2017)
  • Source
    USFDA