Reported Jul 19, 2017 · Terminated

Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The Proclaim implantable…

St. Jude Medical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: St. Jude Medical, Inc. · 6901 Preston Rd · Plano, TX · 75024-2508

Is this the product you have?

Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only
STERILE EO Product UsageThe Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs

Lot codes and dates: 3,260 of 3,260 codes
AAD135.1
AAD136.1
AAD137.1
AAD138.1
AAD139.1
AAD141.1
AAD145.1
AAD153.1
AAD158.1
AAD162.1
AAD164.1
AAD165.1
AAD166.1
AAD170.1
AAD171.1
AAD173.1
AAD176.1
AAD178.1
AAD179.1
AAD181.1
AAD182.1
AAD186.1
AAD191.1
AAD196.1
AAD198.1
AAD205.1
AAD209.1
AAD215.1
AAD217.1
AAD221.1
AAD225.1
AAD226.1
AAD228.1
AAD234.1
AAD236.1
AAD237.1
AAD238.1
AAD242.1
AAD243.1
AAD263.1
AAD265.1
AAD275.1
AAD277.1
AAD278.1
AAD287.1
AAD288.1
AAD289.1
AAD290.1
AAD293.1
AAD296.1
AAD307.1
AAD319.1
AAD324.1
AAD325.1
AAD326.1
AAD331.1
AAD335.1
AAD336.1
AAD338.1
AAD344.1
Amount recalled: 9529 units

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

Nationwide

Why it was recalled

The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.

This product could cause temporary or reversible health problems — stop using it.

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