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FDA Reissues Eon and Eon Mini IPG Recall

Destiny Baker3 years ago

The U.S. Food and Drug Administration recently reissued a recall for the St. Jude Medical Eon and Eon Mini Implantable Pulse Generator (IPG) after reports of battery failure and burn injuries.

Details of the Eon and Eon Mini IPG Recall

  • The FDA has classified the IPG recall as a Class II recall.
  • Recalled IPG models:

    • Eon (65-3716)
    • Eon Mini (65-3788)
  • The recall applies to all 70,638 distributed units of Eon and Eon Mini IPG.
  • There have been reports of the IPG device batteries failing to hold a charge, losing power unexpectedly, and overheating causing burn injuries.
  • As of 2012, the FDA had received 325 reports of battery issues in the IPG with 72 of those resulting in device removal.

Injuries and Complications Associated with the Eon and Eon Mini IPG

  • 1st Degree Burns
  • 2nd Degree Burns
  • Device Removal (Explant Surgery)

    • Pain
    • Scarring
    • Infection
    • Complications with Anesthesia
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