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 Problems
Depression (2361); Convulsion/Seizure (4406); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)
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Event Date 04/17/2023 |
Event Type
Injury
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Event Description
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It was reported that, since implant, the patient has been feeling more depressed and referred to it as "going fetal in a dark room." the caller indicates that when they changed the settings, they were laughing hysterically and feeling like singing james brown.The caller wants to know why they cannot be somewhere in the middle of that.The healthcare provider (hcp) gave them zoloft but they don't want to be on zoloft, they want the device to help the depression.The caller clarified their depression is due to being diagnosed with early onset parkinson's and not due to a chronic depression illness.The patient reports that they have an appointment with their hcp in a couple of months and they want to know if they can adjust the settings to make them feel a little more comfortable.Reviewed that it can be difficult to know which settings are best for the patient and redirected the caller to their hcp to further address the issue.The caller also reported that were not given clear instructions at one appointment and were not told to stop oral meds and as a result they had to turn off therapy because they were having seizures and chronic jerks on their right side.Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported cause the depression, seizures, and other symptoms wasn¿t determined.Programming adjustments were made and were going to be continually made to try and resolve the symptoms.
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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.
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