The Recall Desk

FDA (Devices) recall action 61171

Advanced Neuromodulation Systems Inc. recalled 2 products on 2012-09-05

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2012-09-05
Critical
0
Units
56,948

Why these products were recalled

As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at the implantable pulse generators (IPGs) implant site during charging for the Eon IPG and 116 reports of similar symptoms for the Eon Mini IPG, respectively.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2012-09-05

    Advanced Neuromodulation Systems Recalls Eon Mini Neurostimulation Systems

    Advanced Neuromodulation Systems is recalling Eon Mini Neurostimulation Systems due to reports of warmth or heating at the implant site during charging.

    Product
    The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with 4, 8, and 16 electrode leads. Product Usage: The Eon and Eon Mini Neurostimulation Systems are indicated as an aid…
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2012-09-05

    Advanced Neuromodulation Systems Recalls Eon IPG for Heating Complaints

    Advanced Neuromodulation Systems is recalling Eon IPGs due to reports of warmth or heating at the implant site during charging.

    Product
    Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connected to 4, 8, or 16 electrode leads or a lead extension. Product Usage: The Eon and Eon Mini Neurostimulation Systems are indicated as an aid in the management of chronic intractable pain of the…
    Category
    Distribution
    1 state