Worldwide Distribution -- USA including states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, DC, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MI, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and countries of Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jamaica, Jordan, Kuwait, Lebanon, Macedonia, Martinique, Netherlands, Netherlands Antilles, Norway, Oman, Peru, Poland, Portugal, Puerto Rico, Qatar, Reunion, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom Vatican City State, Venezuela, and Virgin Islands.
Description du dispositif
Medtronic RV Lead Integrity Alert , Cat. # SW012, 1.0 software in EnTrust(R) (D153ATG, D153VRC, D154ATG, D154VRC) and EnTrust(R) Escudo (D144DRG, D144VRC) defibrillators.
“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.