Events

Device Recall StrataMR Adjustable Valves & Shunts 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Neurosurgery 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
    76595
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1702-2017
  • 사례 시작날짜
    2017-02-22
  • 사례 출판 날짜
    2017-04-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-09-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153618
  • 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
    Shunt, central nervous system and components - Product Code JXG
  • 원인
    Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the stratamr locator tool: when the stratamr valve is set in the incorrect orientation, higher valve opening pressures result leading to a corresponding underdrainage in csf fluid performance. this condition may result in the following adverse health consequences: ventriculomegaly, headaches, nausea, vomiting and lethargy. if left untreated, underdrainage has the potential to lead to coma and death.
  • 조치
    The firm has initiated a CAPA and issued notification via letter to US Customers on February 22, 2017. As of the date of the report (2/22/17) the firm was still in process of notifying foreign customers. Recipients are instructed to: 1) Cease use of the listed product, 2) Account for number of product units implanted or discarded and return any unused units by completing an attached individualized customer product accountability form provided in the letter, 3) If any of the indicated products have been implanted in patients, to adjust the valves according to instructions listed in an included attachment. Recipients are asked to fax a customer acknowledgment response form or scan/take a picture of the form and email to rs.mnsfca@medtronic.com with "StrataMR Recall" in the subject line.

Device

Device Recall StrataMR Adjustable Valves & Shunts
  • 모델명 / 제조번호(시리얼번호)
    Worldwide Catalog Number 42955, VALVE 42955 FP-STRATAMR SMALL E03581, E04352, E05120, E05121, E06139, E06476, E09475, E11656, E12556, E12753, E13482, E13483, E13484, E13641, E14518, E14519, E18555, E18556, E18557, E18558, E19670, E19866 Catalog Number 42965, VALVE 42965 FP-STRATAMR REGULAR E03582, E04353, E06015, E06016, E06138, E06412, E09619, E11655, E12041, E12265, E12266, E12950, E12951, E12952, E12953, E13485, E13698, E18559, E18560, E19084, E19540, E19671, E19867, E22208, E22242 Catalog Number 46955, ASSY 46955 FP SHUNT STRATAMR SMALL E12752, E12932, E13573, E16247 Catalog Number 46960, SHUNT 46960 SNAP STRATAMR SMALL E12273, E12780, E12934, E14748 Catalog Number 46965, ASSY 46965 FP SHUNT STRATAMR REGULAR E12779, E12933, E13576, E14270 Catalog Number 46970, SHUNT 46970 SNAP STRATAMR REG E12272, E12620, E12935
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Product was distributed throughout the US and to Australia, Belgium, Canada, Finland, Germany, Hong Kong, Israel, Italy, Japan, New Zealand, Norway, Poland, Portugal, the Russian Federation, Singapore, Spain, Sweden, Switzerland, Turkey, and the UK.
  • 제품 설명
    The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasive adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation. || After surgical implantation, the Medtronic Neurosurgery StrataMR valves provide a non-invasive method to address changing patient needs in the management of hydrocephalus. The valve design enables the physician to adjust the valve pressure/performance level using the Medtronic StrataMR Adjustment Tools. The StrataMR valves are intended to maintain performance level setting under magnetic resonance imaging (MRI) exposure when scanned in accordance with the MRI conditions in the labeling. The StrataMR valves, small and regular, provide the full range of performance levels: 0.5, 1.0, 1.5, 2.0, and 2.5. The currently set performance level is discernible through use of the Indicator Tool or by x-ray (for corresponding settings, refer to figure 6). The dome is designed to allow needle puncture via a 25-gauge or smaller noncoring needle. The StrataMR valve can be flushed in either the distal or proximal direction by percutaneous finger pressure. Occluders are located proximally and distally to the central reservoir on the StrataMR valve regular and only distally on the small model to facilitate selective flushing.
  • Manufacturer
    Medtronic Neurosurgery

Manufacturer

Medtronic Neurosurgery
  • 제조사 주소
    Medtronic Neurosurgery, 125 Cremona Dr, Goleta CA 93117-3083
  • 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