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MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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| Model Number 37601 |
| Device Problems
High impedance (1291); Low impedance (2285); Patient Device Interaction Problem (4001)
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| Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 02/09/2021 |
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Event Type
malfunction
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Manufacturer Narrative
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Information references the main component of the system and other applicable components are: product id neu_ins_stimulator lot# serial# unknown implanted: explanted: product type implantable neurostimulator product id neu_ins_stimulator lot# serial# unknown implanted: explanted: product type implantable neurostimulator product id neu_ins_stimulator lot# serial# unknown implanted: explanted: product type implantable neurostimulator product id neu_ins_stimulator lot# serial# unknown implanted: explanted: product type implantable neurostimulator information references the main component of the system.Other relevant device(s) are: product id: neu_ins_stimulator, serial/lot #: unknown, ubd: , udi#: ; product id: neu_ins_stimulator, serial/lot #: unknown, ubd: , udi#: ; product id: neu_ins_stimulator, serial/lot #: unknown, ubd: , udi#: ; product id: neu_ins_stimulator, serial/lot #: unknown, ubd: , udi#:.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Haider alaa mohammed ali, siham sabah abdullah, moneer k.Faraj.High impedance analysis in recordings of deep brain stimulation surgery.Doi.Org/10.1016/j.Inat.2021.101115 background: deep brain stimulation (dbs) is used widely today to control many chronic neurological disorders including parkinson¿s disease (pd).During surgical procedures, an electric lead wire is inserted to stimulate a specific target of the brain.In practice, such a procedure may result in some complications that limit the clinical benefits of the treatment.Many patients have an elevation of electric impedance for the dbs lead wire which, in turn, has a restraining effect on the delivery of electrical charges with stimulation and therapy outcome coveted.Aim of the study: to analyses the complications that have been involved in dbs surgery of high impedance that affects the therapy outcome covered.Methods: the electric impedances that are inserted into five patients with dbs surgery are followed, prospectively.The impedance of the dbs electrodes is measured for an average of 9 months by utilizing the n¿ vision programmer device (medtronic, inc).Results: the impedance of the electrodes is increased and fluctuated with time.A significant high electrode impedance was noticed.It is caused by the presence of gas bubbles within the dbs electrodes site.The impedance may be changed according to the patient¿s spatial position.This high impedance affects the clinical outcome of the patient¿s condition.Conclusion: while, the impedance measurement has an essential role in follow-up time to get the best therapy results, the surgical technique of the dbs, itself, needs improvement in reducing the impedance issues.Reported events: 1.It was reported that patient 1 had ct images showing air surrounding the electrodes lead wire.Impedance measurements had shown that was reading 1923.25, 3132, 2707.25, 8124.5, 5834.5, 5278.75, and 2837.5 over the course of 218 days.2.It was reported that patient 2 had ct images showing air surrounding the electrodes lead wire.Impedance measurements had shown that was reading 1193.5, 1253, 1345, 114, 1222.5, 1699.5 over the course of 218 days.3.It was reported that patient 3 had ct images showing air surrounding the electrodes lead wire.High impedances were seen at the day of surgery on contacts 0 <(>&<)> 2 recording 4263 and between contacts 0 <(>&<)> 3 5213.Over the course of 218 days they showed readings of 1270.75, 1084.25, 1739, 2707.25.It was also noted that patient 3 had high impedances when changing position, standing or laying supine.They also showed changes when being recumbent for 20 minutes.The patient had readings as "high" during those measurements.In addition, the impedance measurement after 86 days from surgery had shown more increment of a very high impedance level, 11,268.This high reading signified more gathering of air along the dbs lead wire to concentrating on the tip end of the dbs lead.The appearance of gas bubbles may be explained by the presence of the air bubbles within the dbs brain target in advance due to the surgical procedures when the surgeon inserted gently in the patient's head a temporal micro-electrode through a guide cannula then replaced by a permanent one.The micro-electrode recorder (mer) was used to verify the anatomical structure of the best lead wire that was needed to be fitted within the stn or gpi targeting.Following removal of the mer and the inner probe cannula the dbs contacts lead wire was threaded into its guide tube and carefullydriven.On another hand, the inserted mer which was of high impedance (0.1-1.0 ma at 1000hz) and the tungsten-coated stainless steel at 15-25 um tip diameter that was used for a long time during surgery gave rise to the high probability of the gas bubbles formation due to water hydrolyzing process and the by-product substances that were occurring due to electrochemical interactions of the ingredients that filled the dbs target gap between stimulation electric charges.4.It was reported that patient 4 experienced two different impedance measurements simultaneously but in different positions between the standing or supine position.The patient had impedance measurements listed as "high" for these readings.5.It was reported that patient 5 experienced two different impedance measurements simultaneously but in different positions between the standing or supine position.The patient had impedance measurements listed as "high" for these readings.See attached literature article.
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Event Description
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Additional information was received: it was reported that the causes of the air bubbles were believed to be related to surgical technique.The prolonged usage of the microelectrode temporal insertion (mer) may have caused electrochemical interactions.During the replacement between the mer and permanent lead wire through the guide tube.Also could have been the intra space between the insulator rubber cover and the metal plexus of the quadripolar lead wire.The formation of gases as a by -product may have been due to an electrochemical reaction for the electrode-electrolyte interface within the dbs target.The air bubbles were not resolved in the patient's heads, but they changed over time.The high impedances in the patients also did not resolve even though they changed over time, but many were still high.7.Additional information was received: it was reported that 3 patients' measurements noticed an open circuit as their impedance values were more than 40,000 ohms at one point.
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Manufacturer Narrative
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Section d information references the main component of the system and other applicable components are: product id 37601 lot# serial# unknown implanted: explanted: product type implantable neurostimulator product id 37601 lot# serial# unknown implanted: explanted: product type implantable neurostimulator product id 37601 lot# serial# unknown implanted: explanted: product type implantable neurostimulator product id 37601 lot# serial# unknown implanted: explanted: product type implantable neurostimulator product id 37601 lot# serial# unknown implanted: explanted: product type implantable neurostimulator medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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