Device Recall Compia MRI CRTD, Compia MRI Quad CRTD,

  • 모델명 / 제조번호(시리얼번호)
    a. Product No. DTMC1D1: UDI 00643169705807 (Serial No. RPW200289H);  b. Product No. DTMC1QQ: UDI 00643169565272 (Serial No. RPL201034H) (EXPANSION: Serial No. RPL200052H, RPL200534H, RPL201039H, RPL201059H, RPL201235H, RPL201236H, RPL201454H, RPL201645H, RPL201664H, RPL201234H)
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution.
  • 제품 설명
    Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: || a. Compia MRI CRT-D DF1 (Product No. DTMC1D1); || b. Compia MRI Quad CRT-D DF4 (Product No.DTMC1QQ ) || Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), 8200 Coral Sea St Ne, Mounds View MN 55112-4391
  • 제조사 모회사 (2017)
  • 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