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Terminated

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.

FDA Recall Z-2691-2017 · Posted None

Recalling FirmSt. Jude Medical, Inc.
Recall StatusTerminated
Product CodeLGW
Date Initiated2017-06-02
Date Terminated2022-08-24
Product Quantity8780 units

Reason for Recall

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

Firm Action

The notification material is in the form of a Physician Letter and Patient letter which will be delivered to physicians and patients in the US. The physician mailing will be initiated June 2, 2017 for delivery on June 7-9, 2017. The physicians were provided with patient management recommendations, Step for the patient controller updates, and Clinician's Manual Revised Warning. The Patient mailings will begin the week of June 12, 2017 to allow for clinician notification and are expected to be delivered within 3-5 business days. The patient letter informs of them of the potential for the loss of therapy and the steps to receive the software upgrade.

Root Cause

Device Design

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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