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

Model Number 37612

Device Problem Insufficient Information (3190)

Patient Problems Ambulation Difficulties (2544); Paresthesia (4421); Insufficient Information (4580)

Event Date 03/11/2020

Event Type  malfunction  

Event Description

It was reported that, since implant date, the patient has gotten worse.The patient explained that before the ins was implanted, they were golfing, driving, and doing all kinds of stuff.The patient said the only symptoms they had before the ins was implanted was their right hand would shake when they bent over.Ever since the ins was implanted, the patient said the therapy did not help and they got worse, and now they cannot walk.The patient mentioned that they have seen 5 neurologists, and none of them seem to know what the problem is.The patient said they refuse to see the implanter because they think they implanted a faulty ins.The patient said their reason for calling was to find out what would happen if they turned off the ins or if they had it removed.The patient said they would be able to manage if they went back to the way they were before the ins was implanted.The patient was redirected to their healthcare provider (hcp) to further address the issue.The patient's relevant medical history included that their doctor diagnosed them with essential tremor after they had the patient walk 10 feet down a hall and back.The patient indicated that they disagreed with the diagnosis.

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.

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.

Event Description

Additional information received from the consumer reported they saw a different neurologist who did imaging who told them the leads were not in the spot they would have put them in, but they didn¿t provide a solution to this.The consumer had 3 groups, a, b, and c, but have never been reprogrammed.An appointment was scheduled for february 2023, so a request was made for a rep to be at the appointment.It was noted when the consumer adjusted stimulation they felt tingling on their left side but didn¿t feel stimulation on their right when they adjusted it.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTIAL TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16151841
• MDR Text Key: 308739478
• Report Number: 3004209178-2023-00555
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• 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,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2023
• Date Device Manufactured: 09/26/2019
• 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 Age: 69 YR
• Patient Sex: Male