MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37603

Device Problems Energy Output Problem (1431); Device Difficult to Program or Calibrate (1496)

Patient Problems Nausea (1970); Device Overstimulation of Tissue (1991); Discomfort (2330); Shaking/Tremors (2515); Paresthesia (4421)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that when they got their implantable neurostimulator (ins) implanted, the settings were "way too high" because the settings carried over from the previous ins.The high settings on their current ins have kept them nauseated, so they had an appointment with their healthcare provider (hcp) yesterday.The hcp used a clinician tablet to program the ins but they were unable to make the desired programming changes to groups a, b, c, and d.They attempted to clarify by stating, "the doctor wasn't able to calculate any other level other than c." the hcp managed to set group c to 3.00 and now their "nausea is a lot better".The hcp told them that they won't be able to program the ins because the patient is using a patient programmer (pp) that is probably "outdated".Their hcp advised them to call to request an updated pp.Compatibility information was reviewed and they were advised to have their hcp call if they need assistance programming with the clinician tablet.The patient stated that they tried to decrease the stimulation level to save battery but their pp would not allow them to decrease it.During the call, the patient was able to sync with the ins on the first attempt, the ins is on, and the settings are on group c at 3.00.The patient changed to group b, which they stated was set to 0, noting that their hand started shaking.It was reviewed how to change groups and how to decrease the stimulation level.The patient confirmed they were able to change back to group c and decrease it to 2.90.However, they felt a tingling in their arm and head that was very uncomfortable, so they increased the stimulation back to 3.00 and confirmed they felt much better.They were redirected to their hcp to further address the issue.

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 PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11339820
• MDR Text Key: 232338657
• Report Number: 3004209178-2021-02782
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000100353
• UDI-Public: 00763000100353
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2022
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 78