“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.
Domestic distribution to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. International distribution to Armenia, Austria, Bangladesh, Belgium, China, Dominican Republic, Finland, France, Germany, India, Ireland, Israel, Italy, Korea, Luxembourg, Malaysia, Nepal, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Sierra Leone, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Tanzania, Turkey, United Arab Emirates, United Kingdom.
Descripción del producto
Single Chamber Temporary External Pacemaker, Model 53401
Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: || a. Visia AF VR ICD DF1 (Product No. DVAB1D1); || EXPANSION: || b. Visia AF" VR ICD DF4 (Product No. DVAB1D4) || 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).
Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: || a. Visia AF MRI VR SureScan ICD DF1 (Product No. DVFB1D1); || b. Visia AF MRI VR SureScan ICD DF4 (Product No. DVFB1D4); || EXPANSION: || c. Visia AF MRI S VR SureScan ICD DF1 (Product No. DVFC3D1); || d. Visia AF MRI VR SureScan DF4 (Product No. DVFC3D4) || 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).
Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: || a. Evera S DR ICD DF1 (Product No. DDBC3D1); || b. Evera S VR ICD DF1 (Product No. DVBC3D1); || c. Evera S VR ICD DF4 (Product No. DVBC3D4); || d. Evera XT DR ICD DF1 (Product No. DDBB1D1); || e. Evera XT VR ICD DF1 (Product No. DVBB1D1); || f. Evera XT VR ICD DF4 (Product No. DVBB1D4); || EXPANSION: || g. Evera S DR ICD DF4 (Product No. DDBC3D4); || h. Evera XT DR ICD DF1 Gold (Product No. DDBB1D1G); || i. Evera XT DR ICD DF4 (Product No. DDBB1D4) || 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).