The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the conne

FDA device recall Z-0025-2013 · posted 2012-10-09 · Terminated

Recall details

Recalling firm

Advanced Neuromodulation Systems Inc.

Reason for recall

Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimulation that would be felt by the patient as uncomfortable or painful. SJMs routine testing, monitoring, and analysis of manufacturing processes identified three lots of Eon Mini IPGs that the internal battery has the potential to come into contact with the internal microcontroller board.

Action taken

ST. Jude Medical sent an important Medical Device Advisory letter dated September 4, 2012 to all affected customers. The letter identified the affected product, problem and recommended actions to be taken. For questions contact your St. Jude Medical Neuromodulation Division Representative or call the Technical Services Department at 1-800-727-7846.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LGW

Quantity affected

56 units

Distribution

US Nationwide Distribution

Date initiated

2012-09-04

Date posted

2012-10-09

Date terminated

2014-05-12

Location

Plano, TX