Marquis VR 7230, Marquis DR 7274, InSync Marquis 7277
모델명 / 제조번호(시리얼번호)
제품 설명
Medtronic implantable defibrillators, models: Marquis VR 7230, Marquis DR 7274, InSync Marquis 7277.
There are 805 potentially affected devices manufactured by Medtronic before April 2003 that have been distributed in the UK, 791 of which are believed to be still implanted. These include 289 Marquis VR 7230 devices, 402 Marquis DR 7274 devices and 100 InSync Marquis 7277 devices with serial numbers within the following ranges:
“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.