| Model Number 37612 |
| Device Problem
High impedance (1291)
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| Patient Problems
Muscular Rigidity (1968); Neurological Deficit/Dysfunction (1982); Visual Impairment (2138); Visual Disturbances (2140); No Known Impact Or Consequence To Patient (2692)
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| Event Date 01/01/2019 |
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Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 3389s-40, lot# va1c694, implanted: (b)(6) 2016, product type: lead.Other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(4), ubd: 31-aug-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a healthcare provider (hcp) via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins) for the treatment of dystonia and movement disorders.The caller stated the ins was interrogated on the day of the call but the left lead was showing as good and the right lead had high impedance issues.The caller stated the impedance summary tab showed green but in the electrode impedance tab, all of the monopolar and bipolar pairs were red xs.The caller stated therapy impedances and current drain were normal around 950 ohms and 3-4 ma.The caller was not with the patient or hcp to do further troubleshooting.The caller indicated the patient was seen in (b)(6) and all of the impedances measurement showed the same thing as the day of the report.No symptoms or complications were reported or anticipated.
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Manufacturer Narrative
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Product id: 3389s-40, lot# va03csw, implanted: (b)(6) 2012, product type: lead; product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id: 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id: a610, serial# unknown, product type: software; product id: 3389s-40, lot# va1c694, implanted: (b)(6) 2016, product type: lead.Updated to adverse event and product problem.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from a manufacturer representative (rep) indicating the cause of the high impedances was not determined.The issue is not yet resolved.This information was confirmed with the physician.A summary of the issue was provided: right gpi has electrode impedances all within normal range, only right gpi is reported, all results showing ¿high¿, on tablet, customer reported that summary screen showed all electrodes ¿green¿, but then hit ¿electrode¿ tab to see the individual number results and all were ¿red¿ and marked ¿high".The patient was presented at the healthcare provider's office without dystonic posturing in his left hand that he and his mother reported as happening sporadically over the past 3 weeks.Visual disturbances were also reported (black and white dots at times but more recently, lines through his vision) over the same period of time.They did not have any visual disturbances initially at the visit.Lastly, he reported that since the (b)(6) 2018 surgery they can feel the right extension "tightening" in their neck, which they did not have prior to surgery.Steps taken included the following: left chest interrogated with tablet: electrode impedance measurements taken, results were all within normal range.Therapy impedance measurement's taken, results within normal range.Consistent with all follow-ups from (b)(6) 2018 surgery.Right chest interrogated: electrode impedance measurements taken, summary tab-all contact's "green".The electrode tab-all unipolar and bipolar results show "red x, high".Therapy tab-results within normal range.Same thing was seen with the tablet.A discrepancy was noticed in tablet vs.8840 electrode impedance results.During and after electrode impedance testing, patient experienced visual disturbances with "lines" through his vision.That remained constant through the end of the appointment.When impedances were interrogated with the 8840 at 3.0 volts, all results were within normal range for all unipolar and bipolar configurations.They were almost exactly the same as (b)(6) 2018 pre-post surgery.The unipolar and bipolar results are similar for c and 9, c and 10, 9 and 10, all around 850 ohms on average.Positional movement or palpation impedance tests were not assessed due to the patient being uncomfortable.In order to address the visual disturbances, the voltage was decreased from 3.6v to 2.5v, no effect in relieving.Pulse width was decreased from 160 to 120 microseconds (with 2.5v amplitude), no effect in relieving.Settings were increased back to initial settings at visit.The patient was seen again since the follow-up and was still experiencing visual disturbances at different times, but last night had several "dystonic storms".They could not determine with certainty if this is related to the therapy.They decided to change the electrode configuration on the right gpi setting to 11+, 9-, 3.5 volts, 160 microseconds, 80 hz (previously 10+, 9-).Upon slow titration, the patient experienced some of the same visual disturbances but this seemed to resolve past 2.2 volts all the way to the final setting of 3.5 volts.His therapy impedance with this setting was 1499 ohms, 2.3ma, much improved over the previous setting.Electrode impedances were not taken since it brought about more visual disturbances and they did not want to confuse the results.The therapy impedance proved the integrity of the system with this electrode configuration.The patient left the office with no visual disturbance and in good clinical condition.Both, physician and patient, were happy with this result and the healthcare provider will stay in touch with the patient to see how he is doing.
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Event Description
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Additional information was received with troubleshooting steps.It was stated that a software engineer analysed the issue by stepping through the code app and decoding the data report.The issue being analyzed was clarified to be the following: the electrode impedances on the lead implanted in right gpi were healthy for 8840 and when tested with the tablet at.7v and 1.5 v, the summary tabs showed electrodes as green, but the electrode impedance tab showed all open circuits (>10k, >20k).After analysis was completed by the employee, it was found that the actual impedance values reported by the device for 8-11 right gpi lead were within normal range.The discrepancy between the 8840 and the summary's.Detail tabs were due to two reasons.The first reason was in the device memory, the lead type was correctly set to lead 1x4, but the tip numbers were configured as 0 and 8.It was speculated that the tip numbers weren¿t updated when the lead from the left hemisphere was removed.During the impedance test, configured tip numbers were being used to identify the leads configured.So impedances were measured for both 0-3 and 8-11 contacts resulting in high values for 0-3 and normal values for 8-11.The second reason was that the summary screen utilized values for the correct lead (8-11), while the detail screen displayed values from the incorrect lead (0-3).To confirm these findings, a different software engineer followed the steps taken before and came to the same conclusion.It was determined to be an issue with the tablet software.
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Manufacturer Narrative
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Continuation of d11: product id a610 lot# serial# unknown implanted: explanted: product type software product id 3389s-40 lot# va03csw serial# implanted: (b)(6) explanted: product type lead product id 7482a51 lot# serial# (b)(6) implanted: 2012-01-30 explanted: product type extension product id 3708660 lot# serial# (b)(6) implanted: 2012-11-05 explanted: product type extension product id a610 lot# serial# unknown implanted: explanted: product type software product id 3389s-40 lot# va1c694 serial# implanted: (b)(6) explanted: product type lead 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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Event Description
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It was reported that it was still unclear how to proceed with the tablet showing impedance issues and the8840 programmer not.Information was restated regarding reprogramming for vision changes.Impedance results from (b)(6) displayed the same discrepancy as before: the tablet showed >20k for all electrodes and pairs on the right side, whereas the 8840 clinician programmer showed all impedances within normal range.There were no issues with the left side impedances.It was noted there was noallegation against the actual therapy, and it was suggested that the issue was related to the tablet's reading of the impedances.
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Manufacturer Narrative
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Continuation of d11: product id a610 lot# serial# unknown implanted: explanted: product type software product id 3389s-40 lot# va03csw serial# implanted: (b)(6) explanted: product type lead product id 7482a51 lot# serial# (b)(6) implanted: (b)(6) explanted: product type extension product id 3708660 lot# serial# (b)(6) implanted: (b)(6) explanted: product type extension product id a610 lot# serial# unknown implanted: explanted: product type software product id 3389s-40 lot# va1c694 serial# implanted: (b)(6)explanted: product type lead 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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Manufacturer Narrative
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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.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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Search Alerts/Recalls
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