Model Number B35200 |
Device Problems
Premature Discharge of Battery (1057); Malposition of Device (2616)
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Patient Problems
Muscular Rigidity (1968); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2021 |
Event Type
Injury
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Manufacturer Narrative
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Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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 there was possible premature battery depletion.There were no known factors that may have led or contributed to the issue.The battery was replaced with a new percept.It is unknown if the issue resolved.On the session report and under group d programming, the clinician noted "moved cathode down ? away from ic for right arm tightness".
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Manufacturer Narrative
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Section d information references the main component of the system.Other relevant device(s) are: product id 3389s-40 lot# va02wws serial# implanted: (b)(6) 2013.Explanted: product type lead product id 3389s-40 lot# va05t1e serial# implanted: (b)(6) 2013.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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Additional information received from the healthcare provider (hcp) reported moving the cathode down didn¿t resolve the right arm tightness as the lead was too lateral and close to the internal capsule.It was confirmed the tightness was related to the dbs device/therapy.
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Manufacturer Narrative
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Analysis determined that the implantable neurostimulator (ins) output and telemetry were acceptable; however, the battery was near normal battery depletion.Continuation of d10: product id 3389s-40 lot# va02wws, implanted: (b)(6) 2013, product type lead product id 3389s-40 lot# va05t1e, implanted: (b)(6) 2013, 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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Search Alerts/Recalls
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