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

Model Number 37612

Device Problems High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586)

Patient Problems Pain (1994); Electric Shock (2554); Paresthesia (4421); Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that they get a "shock" in their chest near the ins whenever they turn the ins off and turn it back on.The patient explained that they went to mayo annually for routine checkups and noted that a nurse would purposefully have them turn the ins off and turn it back on so they could "get used to doing it." the patient repeated that they would get a shock when they turned the ins off and when they turned it back on.

Manufacturer Narrative

H6: codes added with additional information received.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 was received indicating the shocking only occurred when the system was turned on and off.Other than turning the system on and off, there was no shocking sensation.While records have indicated high impedances, the impedances were ran again and they looked perfect.The patient never turns their system off unless they are having a procedure and indicated to turn it off because their control was so good.Additionally, outside of the shocking, the patient was having trouble charging.The charging takes 50% longer than in the past.

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 was received from the consumer reporting the shocking always happens when turning the device off and back on again.The shocking was not resolved and they noted it is taking longer and longer to charge.

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 was received from the consumer reporting their teeth would tingle when therapy was off.The patient added that they accidentally turned therapy off with the patient programmer once while on vacation in virginia, noting that they got a "big shock" and their teeth felt awful.The patient stated that they called mayo and they were able to walk them through turning the therapy back on.The patient mentioned that the mayo nurse advised them to not use the patient programmer and to just keep up with charging the ins battery.The patient stated that they charge the ins battery 2-3 times a week for this reason.The patient mentioned that their teeth were tingling during the call, but they stated that they knew the therapy was turned on.When agent asked the patient to clarify if their teeth were actively tingling at the time of the call, the patient's response was unclear and they started talking about when therapy had been turned off in the past.Therapy status was unable to be confirmed because the patient did not have their patient programmer with them at the time of the call.The patient was redirected to their healthcare provider to further address t he issue.

Event Description

Additional information was received from the patient that the shock was mild in 2016-2018, but in the last 3-4 years, it got worse.The patient said the shocking sensation had been far worse in the previous year, and they weren't sure if it was because they were getting older or related to the ins.When stimulation is turned off, the shock starts in their chest, up their neck, and into their cheek.That lasts a whole minute, and the pt cannot speak because their teeth hurt so much.Pt said they gasped and clung to the side of the bed for a minute.Pt said turning it on was not as bad as turning it off, but the first time it was ever turned off for their first yearly dbs check, they almost "jumped off the ceiling" ((b)(6) 2016).The patient said they try to follow up with their hcp once a year to have the ins checked.The patient was redirected to their hcp to address the issue further.

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 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: 11454083
• MDR Text Key: 238884619
• Report Number: 3004209178-2021-04027
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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,Followup,Followup,Followup
• Report Date: 03/16/2023

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: 12/14/2015
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 04/22/2021; 06/02/2021; 12/28/2021; 03/13/2023
• Supplement Dates FDA Received: 05/06/2021; 06/07/2021; 01/10/2022; 03/16/2023
• Date Device Manufactured: 01/19/2015
• 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 Sex: Female