MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number B35200 |
Device Problems
Failure to Deliver Energy (1211); Energy Output Problem (1431); Insufficient Information (3190); Data Problem (3196)
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Patient Problem
Shaking/Tremors (2515)
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Event Date 09/28/2022 |
Event Type
malfunction
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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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Event Description
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It was reported that after the patient's doctor's appointment, they noticed tremor on their left hand and they went to try and adjust it but noticed there is no longer any left side adjustment available in their handset.Before yesterday they had the ability to adjust stim on the right and on the left side.The patient said the doctor wrote the post appointment note showing they were leaving the settings for now.The patient said as far as they know, the doctor did not do anything to their settings.The call agent worked with the patient to synch with their ins.The patient navigated to their therapy and reported there was no group letter or number at the top and arrows and 1.5 appeared on the right side but no arrows on the left and they saw the number zero where there are normally numbers on the left.The patient tried to "revert" their group, however, there was no change to the screen icons.It was reviewed it seems there was some change made to their therapy settings yesterday and they do not have the ability to recover their prior set ting on their own.The issue was not resolved.The patient was redirected to their healthcare provider to further address the issue.
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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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Event Description
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Additional information received from the healthcare provider (hcp) reported the cause of the left-side therapy settings changing/not being available was due to them trying to turn the dbs sensing technology on which turned the settings to nothing.The hcp turned the settings back to what they were previously which resolved the issue.
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