FDA Device Recall Z-0025-2013: Advanced Neuromodulation Systems Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0025-2013.

Recall Res Number

Z-0025-2013

Recalling Firm / Manufacturer

Advanced Neuromodulation Systems Inc.

FEI Number

1627487

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2012-09-04

Date Posted

2012-10-09

Date Terminated

2014-05-12

Product Code

LGW

Event Number

63154

Product Quantity

56 units

Product Description The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.

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 Details 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.

Distribution Pattern US Nationwide Distribution

Code Information / Serial Numbers Eon Mini - 3788 (IPG), Multiple Serial Numbers

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Medical Device Recall: Z-0025-2013

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer