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Advanced Neuromodulation Systems Recalls
5 recalls on record · July 18, 2012 to March 6, 2013 · Medical Devices
Recalls by year
12
13
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 6, 2013Medical DevicesFDA
Advanced Neuromodulation Systems Inc. recalls Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pul
Hazard: Unintended Fluid ingress into the device header has been shown.
October 17, 2012Medical DevicesFDA
Advanced Neuromodulation Systems Inc. recalls The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the conne
Hazard: 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.
September 5, 2012Medical DevicesFDA
Advanced Neuromodulation Systems Inc. recalls The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows
Hazard: As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at the implantable pulse generators (IPGs) implant site during charging for the Eon IPG and 116 reports of similar symptoms for the Eon Mini IPG, respectively.
September 5, 2012Medical DevicesFDA
Advanced Neuromodulation Systems Inc. recalls Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connected to 4, 8, or 16 electrode leads or a
Hazard: As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at the implantable pulse generators (IPGs) implant site during charging for the Eon IPG and 116 reports of similar symptoms for the Eon Mini IPG, respectively.
July 18, 2012Medical DevicesFDA
Advanced Neuromodulation Systems Inc. recalls Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the management of chronic
Hazard: The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or recharge due to a workmanship issue resulting in loss of pain relief and subsequent explant. The firm has determined the cause of these reports to be related to process variances in the positioning of the internal battery and printed circuit board, causing a short, and therefore, prematurely depletin