MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number B35200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Nausea (1970); Depression (2361); Irritability (2421); Shaking/Tremors (2515); Ambulation Difficulties (2544); Cognitive Changes (2551); Insufficient Information (4580)

Event Date 10/06/2021

Event Type  Injury  

Event Description

Patient services (pss) received call from patient rep in regards to the patients therapy.The caller stated that the patient was implanted with the percept pc around (b)(6) 2021.The caller stated that prior to seeing the neuro specialist at (b)(6), the doctors did not know what was wrong with the patient and several of them stated she did not have parkinson.When they saw the specialist they did diagnose the patient with parkinson's.The healthcare provider (hcp) prescribed the patient with sinemet, and the patients symptom's resolved immediately.The caller stated the patient never had much of a tremor, and felt the symptoms ( shaking trembling ) more inside.The caller stated that the patient then saw another hcp ( did not name) and that's when the patient decided to have the implantable neurostimulator (ins) implanted.The caller stated after the surgery, that's when the patient really started plummeting into the parkinson's symptom's.The caller stated that the patient is apart of the 40% of patients that experience psychosis and delusions.The caller stated that when the patient went in for programming , they were given two different groups ( a , b) with different permeameters.The caller stated that four or five months after the ins had been turned on the patient went into a severe depression.The caller stated that during the 4-5 months they would experiment with the different settings/programming that fit the patient the best.The caller stated that when they changed the patients group they weren't having any symptom's of depression, but then would become angry/aggravated.The caller stated that the patient started to experience symptom's of nausea and their legs being heavy, so they decided to change the patient back to the other group.The caller stated when they changed back to the other group, the patient would become depressed again.The caller stated they would experiment with between the patients two groups ,and within hours could see the patient go from depression versus hyper/manic/aggression.The caller stated they believe the dbs is causing problems with the patients emotions.The caller stated that after weeks they decided to turn the ins off and the patient returned to being fairly normal.The caller stated at that time the dbs did not help the patient because the patient did not have a tremor and not much dyskinesia.The caller stated that they informed a nurse practioner (np) of the issues with the patients emotions, and the np told them to keep the ins turned off.The caller stated that the patient mainly follows up with the np.The caller stated that they saw the neuro specialist last march at (b)(6) and informed them the dbs had been off for the last year and half at the recommendation of the np.After the caller reported the same symptoms to the hcp, the hcp ordered an mri for lead placement.The hcp stated that the mri showed nothing was wrong, and the leads had not moved.The caller stated that nothing was wrong with the dbs, and was told by the hcp to leave the dbs off.The caller stated that now the patient cannot walk very well and wanted to try to turn the dbs back on.The caller stated that this week they turned the dbs on , and turned the patient on to group b.The caller stated that after they turned the dbs on the first day, the patient was walking around the house pretty decently.The caller said by the second day, the patient was starting to experience the depressive symptoms again.The caller stated they turned the dbs off again and two days later the patient was back to normal.The caller stated that they decided to turn the dbs on again but to group a.The caller stated the next day the patient crashed all day with her parkinson's and had to turn the dbs off again.Patient services (pss) redirected the patient to the hcp again to further assist with programming.Pss encouraged the caller to have the hcp invite the reps to the appointment to assist with programming.The caller stated that the patient has not had any additional dbs programming since the initial programming session when the patient was first implanted.

Manufacturer Narrative

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.

• Brand Name: PERCEPT
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18681482
• MDR Text Key: 335073766
• Report Number: 2182207-2024-00608
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Female