Model Number 37612 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cognitive Changes (2551); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Event Description
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It was reported that the patient's subjective satisfaction with efficacy was high one month after surgery, but the condition began to recur in the second month after the surgery, and the patient returned to the hospital for debugging again on (b)(6) 2022.The doctor advised the patient to shut down.During this period, the doctor suggested that the patient do an mri review of the target location, but the patient did not go to the hospital for a review.Recently, the family informed that the patient committed suicide by drinking pesticides at home on february 24 this year.He had been rescued and discharged from the hospital.At present, feedback has been given to the patient's attending doctor, and the doctor asked the patient to return to the hospital for relevant medical examination and review, and then conduct follow-up treatment.The patient is currently under observation at home.
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Manufacturer Narrative
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The event date is unknown.If information is provided in the future, a supplemental report will be issued.
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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 was received from a manufacturer representative (rep) reporting that it is unknown if the suicide attempt was caused by or related to the dbs device/therapy.The cause of the event is unknown.It is unknown if the patient returned to the hospital for further evaluation and unknown if further steps/actions are being taken/planned to resolve the symptoms.It is unknown if the issue resolved.
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Search Alerts/Recalls
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