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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Event Detail

Event ID 63108
Product Type Devices
Status Ongoing
Recalling Firm St. Jude Medical
City Plano
State TX
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-26
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution--USA (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Belgium, Brazil, canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Saudi, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Eon Mini - 3788 (IPG), 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. Multiple lots recalled are the ones with supplier's inner battery lots of 326-508 Class II As part of St. Jude Medical's routine tracking and product monitoring, they have received a total of 214 reports, out of 34,617 Eon Mini IPGs, that lost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant. Explant surgery, as with any surgery, presents a risk to patient health. Adverse events associated with an unplanned surgery may be comparable to adverse events associated with planned operations, and may include pain, scarring, and infection, as well as complications from anesthesia. Product investigation and analysis conducted by St. Jude Medical as a result of reports of the inability to communicate or recharge the Eon Mini IPG has identified weld cracks in the IPG's inner battery as the cause of this issue. Prior analysis had indicated that moisture was the cause of weld cracking. However, with the occurrence of additional weld cracks, the firm's investigation has determined that the current weld cracks are not attributed to moisture within the battery. Thorough analysis of the cracked batteries and review of the battery manufacturing processes has identified a need to more frequently maintain and replace certain tools during the internal battery welding process by a St. Jude Medical supplier in order to assure complete alignment between the welding apparatus and the battery. It is important to note that the battery is contained within the hermetically-sealed IPG case and cannot leak electrolyte outside the IPG casing. 34,617 Z-1836-2013