Model Number 37603 |
Device Problems
Intermittent Continuity (1121); High impedance (1291); Low impedance (2285); Impedance Problem (2950)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Manufacturer Narrative
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No information available for event date.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 consumer via a manufacturer representative regarding a patient with an implantable neurostimulator ( ins) for the treatment of dystonia and movement disorders.It was reported the patient had impedance issues.They were suspecting an open circuit and wanted to know if this also affected the compatibility with magnets.No other information is known.It was unknown if the patient was programmed around this issue.No symptoms were reported.No complications were reported or anticipated.
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Manufacturer Narrative
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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 the healthcare professional via the manufacturer representative stating the cause of the open circuit was undetermined but the patient was programmed to avoid the issue.It was reported no further action would be taken.
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Manufacturer Narrative
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Fdd (b)(4) no longer valid.Replaced with fdd(b)(4).If information is provided in the future, a supplemental report will be issued.
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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 37085-60 serial# (b)(4).Implanted: (b)(6) 2012 explanted: 2015-03-25 product type extension product id 37603 serial# (b)(4).Implanted: (b)(6) 2015.Product type implantable neurostimulator medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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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Additional information was received.It was reported the devices have been explanted and replaced due to normal battery depletion in february 2019.It was discussed that there was a revision that occurred in march 2015, which was the replacement of the left extension due to the patient having electrical sensations intermittently.This replacement resolved the issue.It was also reported that contact 3 had an open circuit before the replacement, after the replacement this resolved.No further complications were reported as a result of this event.
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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.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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Search Alerts/Recalls
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