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St. Jude Medical, Inc. recalls Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The Proclaim implantable
Recalled July 19, 2017 · FDA recall Z-2692-2017 · St. Jude Medical
Hazard
The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures. · FDA Class II
Units
9529 units
Sold at
US Nationwide Distribution
Description
The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
Product
Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The 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.
Manufacturer(s)
St. Jude Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →