Eon Mini Neurostimulation (IPG) System Model 3788 System is indicated as an aid in the management of chronic intractable

FDA device recall Z-2607-2011 · posted 2011-06-22 · Terminated

Recall details

Recalling firm

Advanced Neuromodulation Systems Inc.

Reason for recall

Defective battery was identified as cause for reports of inability to communicate or recharge the product.

Action taken

St. Jude Medical sent an "IMPORTANT MEDICAL DEVICE RECALL" letter dated May 24, 2011 to all affected customers. The letter describes the product, problem and actions to be taken by the customers. St. Jude Medical recommends no action be taken if the product serial numbers do not match the numbers listed in the letter. For product remaining in unimplanted inventory, customers are instructed to contact their SJM representative so that product may be returned and replacements be provided. For implanted product that matches the serial numbers, the Medical Advisory Board recommend not to unnecessarily explant the devices if they are functioning as intended. Replacement devices will be provided at no additional cost to the customer. A Product Reconciliation Form was attached to the letter for customers to complete and return any unused product to the St. Jude Medical Neuromodulation Division at 6901 Preston Road., Plano, TX 75024. Questions regarding this recall are directed to the customer's St. Jude Medical Neuromodulation Division Representative.

Root cause

Process control

Status

Terminated

Product code

LGW

Quantity affected

17,141

Distribution

Worldwide Distribution-- USA (nationwide) including PUERTO RICO and countries of AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, FINLAND,FRANCE, GERMANY, GREECE

Date initiated

2011-05-24

Date posted

2011-06-22

Date terminated

2015-07-21

Location

Plano, TX