MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number B35200 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Seizures (2063)
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Event Date 07/18/2020 |
Event Type
Injury
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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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It was reported that the patient had an increase in seizures.The patient had surgical abandonment/capped of the lead and the therapy was suspended on (b)(6) 2020.The patient was in intensive care because of focal convulsions for a total of six days.Additionally, the patient was hospitalized with epilepticus on (b)(6) 2020.The patient decided to have resective epilepsy surgery.The issue was possibly related to the device or therapy, however, it was unrelated to the implant procedure.
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Event Description
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Device implant date received.
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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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Manufacturer Narrative
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Section d information references the main component of the system, other applicable components are: product id neu_unknown_lead lot# unknown serial# implanted: explanted: (b)(6) 2020 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.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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The patient was hospitalized with status epilepticus on (b)(6) 2020.Deep brain stimulation (dbs) was turned off because of no more therapeutic options, including an initial decrease in the number of attacks, but an increase afterwards.The issue was possibly related to the device or therapy, not due to programming, and was unrelated to the implant procedure.The event was unresolved at the time of study exit/closure/death.Additional information was received which corrected the intervention reported.The intervention of surgical abandonment/lead capping was updated to explant of lead without replacement.
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Search Alerts/Recalls
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