The Recall Desk

FDA (Devices) recall action 63109

St. Jude Medical recalled 2 products on 2013-07-24

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
2013-07-24
Critical
0
Units
141,276

Why these products were recalled

St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their spinal cord stimulator. In three cases, patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. As of June 30, 2012, St. Jude Medica

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)··2013-07-24

    St. Jude Medical Recalls Eon Spinal Cord Stimulator Charging Systems

    St. Jude Medical is recalling Eon and Eon Mini charging systems due to reports of skin burns and discomfort at the implant site during use.

    Product
    Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syn
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2013-07-24

    St. Jude Medical Recalls Eon Mini Spinal Cord Stimulator Chargers

    St. Jude Medical is recalling Eon Mini chargers due to reports of skin burns and discomfort at the implant site during charging.

    Product
    Eon Mini - 3721 (Charger). Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back
    Category
    Distribution
    1 state