Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 ba — recall Z-2691-2017

U.S. FDA — Device Enforcement · United States · 2017-06-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2691-2017
Date of alert: 2017-06-02
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: St. Jude Medical, Inc.
Product category: device
Product type: Devices

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

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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