MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
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Model Number B35200 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Shaking/Tremors (2515); Paresthesia (4421); Suicidal Ideation (4429)
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Event Date 06/22/2023 |
Event Type
Injury
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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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Event Description
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It was reported that the patient had a tingle from their mouth to their left had when they woke up and turned over in bed.It was only for a quick second and has not occurred anymore.The patient had increased the settings some to help some residual tremor.Tremor did improve when the dbs was increased but the therapeutic effect seems to diminish over time.This hand has always been less controlled than the right hand since implant so this is not anything new.The patient said that the new percept seems to help steady the tremor better that what the old sc used to do though.The issue was resolved at the time of this report.Additional information received from the manufacturer¿s representative (rep) reported the patient was hospitalized because of suicidal ideations which was related to frustration over the increase in tremors.The tremor in their right hand came back so their healthcare provider (hcp) increased their stimulation on july 12th while in the hospital which seemed to improve their tremor.The patient spoke with the rep on july 15th saying the improvements made at the hospital were now gone and the tremor was back.The patient was going to try and use their programmer to increase the settings to see if it could improve their tremor, but ultimately saw the physician on the 17th and stimulation was changed to different contacts and parameters which so far seemed to have helped with their tremor.
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Event Description
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Additional information received from the manufacturer¿s representative (rep) reported the patient¿s tremors in both hands hadn¿t been as controlled with the new primary cell devices as they were when they had rechargeable devices.The healthcare provider (hcp) was going to bring them back in the next week or so to try reprogramming.
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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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