INSIGNIA Entra and NEXUS Entra

  • Model / Serial
    Affected devices may be found in the following serial number ranges. INSIGNIA Entra SSI (model 0484) serial no. 100879 - 115237; (model 0485) serial no. 100088 - 100104; NEXUS Entra SSI (model 1326) serial no. 100122 - 100175. INSIGNIA Entra DDD (model 0985) serial no. 100059 - 100089; (model 0986) serial no. 100600 - 104439; NEXUS Entra DDD (model 1426) serial no. 100032 - 100091. INSIGNIA Entra SR (model 1195) serial no. 100739 - 101623; (model 1198) serial no. 102498 - 117468; NEXUS Entra SR (model 1398) serial no. 100067 - 100120. INSIGNIA Entra DR (model 1294) serial no. 101132 - 107445 & 292190; (model 1295) serial no. 100503 - 102668; (model 1296) serial no. 101519 - 153064; NEXUS Entra DR (model 1494) serial no. 100028 & 100029.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide and Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Polynesia, Portugal, Qatar, Reunion, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom and Venezuela
  • Product Description
    Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). Intermedics NEXUS Entra family of pacemakers includes the following: SSI (model 1326); DDD (model 1426); SR (model 1398) and DR (model 1494). The INSIGNIA I Entra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Entra pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. The INSIGNIA and NEXUS I Entra adaptive-rate models have an accelerometer, which is a motion sensor that responds to patient activity. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. or Intermedics, Inc., 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Guidant Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5798
  • Source
    USFDA