News Briefs about Device Complications from the International Neuromodulation Society

 

Device Complications News Feed

 


Hazard Alert Issued in Australia for Some Neurostimulation Devices Regarding Potential Loss of Stimulation, Over-Stimulation or Stimulation in the Wrong Area

Feb. 4, 2014 - In consultation with the Australian Department of Health's Therapeutic Goods Administraton, Medtronic Australasia has issued a hazard alert and recall for product correction concerning deep brain stimulation (DBS) and spinal cord stimulation (SCS) models that may pose a potential for loss of stimulation or over-stimulation or stimulation in the wrong area under certain conditions: DBS models Activa PC, Activa RC and Activa SC models 37601, 37602, 37603, 37612 (Activa SC models 37602 and 37603 are not affected by the over-stimulation or stimulation in the wrong area issue); and SCS RestoreUltra and RestoreSensor models 37712, 37714. Avoiding over-discharge is advised for reducing the likelihood of over-stimulation or stimulation in the wrong area -- patients should call 1800 688 670 if their device is over-discharged. At the next visit a software upgrade to the clinician's programmer will correct the potential loss of stimulation issue. (Australian Therapeutic Goods Administration)

Article Explains More About Ranking of Deep Brain Stimulation Lead Cap Recall
May 6, 2013 - International Neuromodulation Society North American Chapter President Ali Rezai, MD was quoted in an article about recall of an optional cap for deep brain stimulation leads, ranked Class 1 by the FDA, saying it would be incorrect to interpret the recall as representing a life-threatening concern -- the maximum consequence under that ranking. The article explained that the cap, which he said he does not use and few other neurosurgeons do, is intended to cover the end of the leads before they are connected to a pulse generator, and may cause lead damage if the cap is twisted or its screw is over-tightened. Lead damage would likely be noticed during the connection step, and the likely result of lead damage would be that the patient would not receive the full benefit of therapy to control symptoms, a result that might be life-threatening in a cardiac arrest treated with a defibrillator, but not when controlling tremor and stiffness of Parkinson's disease or other motor disorders. (Mass Device)
 
Company Issues Urgent Medical Device Correction Notice on Deep Brain Stimulation Lead Caps
May 2, 2013 - Medtronic, Inc. announced it issued an Urgent Medical Device Correction notification in February to inform physicians about the potential for temporary caps sometimes used on deep brain stimulation (DBS) leads to cause twisting damage to the lead. Medtronic received reports of DBS leads being damaged due to twisting of the connector within the lead cap, which is sometimes used to temporarily protect the end of a DBS lead after implantation. The FDA classified the notification a Class 1 Recall. A manufacturing change intended to address the issue is currently under FDA review, and in the meantime Medtronic has issued modified instructions to physicians who may use DBS lead caps. Any malfunctions or adverse events related to a device should be reported to Medtronic Neuromodulation Technical Services at 1-800-707-0933, weekdays from 7 a.m. to 6 p.m. CST, and the FDA's MedWatch Program at http://www.fda.gov/MedWatch. (Wall Street Journal)

Dutch Ministry of Health to Establish Device Registry to Track Complications
January 2013 - The Dutch Ministry of Health plans a national registry for patients who have received medical implants. In it, suppliers, producers, and insurance companies will be required to provide information on any device complications. (Dutch News via The Commonwealth Fund)

Japan Team Finds Short Circuits in Deep Brain Stimulation Patients
Sept. 7, 2012 - After following nearly 80 patients for a year who had received deep brain stimulation (DBS) surgery, a clinical research team in Japan determined that 7 (8.9%) had developed short circuits and conclude that short circuits in DBS may be higher than previously thought, especially in cases in which leads are anchored with miniplates. The results stem from their new institutional policy of routinely evaluating impendence at every follow-up visit of DBS patients, regardless of the presence of symptoms. The researchers say short circuits could cause insidious development of neurological symptoms through limited or extended potential fields as well as shortened battery life. (American Journal of Neurological Surgeons)

Battery Issues Lead to Recall of Some Devices
Aug. 12, 2012 - St. Jude Medical Inc. alerted doctors and patients on July 31, 2012 that it is recalling some of its Eon and Eon Mini devices following reports of battery issues. (The Legal Examiner Charlottesville)

Investment Analyst Reportedly Reveals a Halt in European Marketing of Deep Brain Stimulation Device
March 29, 2012 - Leerink Swann analyst Rick Wise was reported to have written in a note to investors that St. Jude Medical had temporarily pulled its Brio deep brain stimulation Parkinson's disease treatment off the market due to a fixable issue of body fluids seeping in and interrupting therapy in 11 of 400 devices implanted so far, according to Mass Device. European customers were being advised to opt for the Libra DBS system during the next 60-90 days, according to the published news report. The Brio system received CE Mark approval in Europe in 2009 and Australian approval in 2010. (MassDevice)

Urgent Safety Action Notice for CareFusion's NicoletOne Products
February 23, 2012 - In an action affecting 132 devices and 35 software licenses, CareFusion is recalling Nicolet Cortical Stimulator Control Unit, Nicolet C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator. The products were manufactured from May 2009 - July 2011 for functional brain-mapping of patients with seizure disorders and brain tumors. The software incorrectly indicates stimulation is delivered to a different electrode than the one selected, and a short circuit may develop. (FDA)

SynchroMed II Pump Model 8637 is Recalled Over Battery Defect
August 30, 2011 - Medtronic's SynchroMed II, model 8637, implantable pump has been recalleddue to a problem that has caused some batteries to abruptly cease working. The FDA has approved a  modification to the battery, designed to prevent the problem from occurring in pumps with the new battery; all Synchromed II pumps are being manufactured with the new battery. Updated 9/1/11 (Mass Device)

Studies Link Rare Ailment to Pain Pumps
January 26, 2010 - (New York Times)

 
     
Last Updated on Friday, June 06, 2014 12:10 PM
 
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