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

Model Number 37612

Device Problem Failure to Deliver Energy (1211)

Patient Problems Dysphasia (2195); Shaking/Tremors (2515); Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 05/01/2023

Event Type  malfunction  

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

It was reported that patient was shaking , can't hold cup, speech is "messed up".Patient stated 2 days ago dr did reprogramming.Patient states before programming she was walking to the right and before leaving the dr office patient was walking straight, hands and head were not shaking.The next morning patient charged implantable neurostimulator (ins) and started shaking and couldn't walk good and couldn't hold a glass.It is like everything the dr did had been reversed.Patient was fine when waking up yesterday morning, running through the house and could talk and write.Now patient cant talk or write, speech is messing up.Patient tried changing equipment to charge ins.Patient stated shaking during recharging.Patient stated changing the settings on the dbs therapy app and had did that before starting to charge.The setting changes dr gave 2.0, 3.0, 3.6 on both sides.Patient went to 3.0 and stopped.During troubleshooting it was found dbs therapy showed ins off.Patient services (pss) asked if patient had someone there while we turned therapy on in case patient felt and shocking.Patient states "i know what the shocks feel like " patients daughter was there to help.When therapy was turned on caller stated patient feeling tingling and not shaking so bad.Dbs therapy app showed left and right at 3.0.Pss redirected to hcp.

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 the cause of the device being off was due to them not understanding the process so they ended turning their device off by mistake and didn¿t realize it until the next morning.

• 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: 16870914
• MDR Text Key: 314588758
• Report Number: 3004209178-2023-05970
• 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: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 05/04/2023
• Supplement Dates Manufacturer Received: 05/23/2023
• Supplement Dates FDA Received: 05/26/2023
• Date Device Manufactured: 05/08/2019
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 52 KG