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

Model Number B35300R

Device Problem Failure to Deliver Energy (1211)

Patient Problems Emotional Changes (1831); Insufficient Information (4580)

Event Date 04/02/2022

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient woke up feeling extremely "off." they checked the settings of both right and left ptm devices.The left side ptm setting was at 0m/a despite being fully charged.Reset left side ptm original setting 3.1.They did not recall the group setting, and the right side setting was 2.7.They went back to sleep and woke up feeling "on" and took morning medications.They began to experience feelings of mania and continued to experiment with the feelings until they did a reset.Left side ptm to group a was 3.1 intensity and didn't recall every changing the group assignment.They were working with the site to get the log files to determine what happened, but the patient was doing well.

Event Description

Additional information was received from a healthcare provider (hcp) reporting that they went through the files/logs and think it might have been a false alarm.It was confirmed that the patient accidentally switched groups when recharging friday night and the new group was on 0ma, which only led to severe symptoms at night due to therapy withdrawal.There was no issue with the device(s).Once this was determined, the patient was returned to the correct group and their symptoms subsided.The cause of the issue was due to user error, which has been confirmed by the logs as well as the physician.The issue was resolved on (b)(6) 2022.

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: ACTIVA
• 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: 14254840
• MDR Text Key: 290446794
• Report Number: 2182207-2022-00726
• 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,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B35300R
• Device Catalogue Number: B35300R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2022
• 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