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FDA issues safety communication regarding certain Medtronic pacemakers

Posted on May 07, 2019 by Medtech[y] Staff

The FDA issued a safety communication alerting providers and patients of three medical device reports where a Medtronic implantable pacemakers or CRT-P battery had fully drained because of a crack in the device's capacitor. During the battery draining process, neither the patient or healthcare provider were given any warning.

The affected Medtronic implantable pacemaker and CRT-P device models include:

  • Azure models: W1DR01, W2DR01, W3DR01, W1SR01, W2SR01, W3SR01
  • Astra models: X1DR01, X2DR01, X3DR01, X1SR01, X2SR01, X3SR01
  • Percepta models: W1TR01, W1TR04, W4TR01, W4TR04
  • Serena models: W1TR02, W1TR05, W4TR02, W4TR05
  • Solara models: W1TR03, W1TR06, W4TR03, W4TR06

Medtronic reported the events occurred within one year from implantation, while the devices are designed to last between 6-15 years depending on what device is used.

Full safety communication here.

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