Recall Z-2691-2017— St. Jude Medical, Inc.

Class II FDA medical device recall by St. Jude Medical, Inc., initiated 2017-06-02, terminated 2022-08-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Proclaim 5 Elite, implantable Pulse Generator, REF 3660, 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.. Reason: The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures..

Recalling firm

St. Jude Medical, Inc.

Classification

Class II

Status

Terminated

Initiated

2017-06-02

Terminated

2022-08-24

Firm location

Plano, TX, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.