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

Model Number 37612

Device Problems Intermittent Continuity (1121); Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); Energy Output Problem (1431); Insufficient Information (3190)

Patient Problems Dysphasia (2195); Ambulation Difficulties (2544); Unspecified Nervous System Problem (4426); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient has been "feeling terrible" and has had no energy over the last couple weeks.When he called his hcp, they wanted him to adjust the medication he was on to see if that would help but it didn't.The patient stated that did not help so he checked his ins with the programmer and discovered his therapy was off.The patient stated that he went to turn the therapy back on and his left side of his body went into "spasm" so he turned the therapy back off.The patient is inquiring if there is a way to decrease the stimulation before turning it back on.They were walked through how to decrease stimulation but he reached the lower limit on the left side at 3.2 (coming down from 3.8) and was prompted to turn stimulation back on when he attempted to adjust the right side down from 3.8.They were advised to see their physician.

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.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 about a month ago their deep brain stimulation (dbs) turned off spontaneously for the third time in 5 years.It took a few days for the patient¿s symptoms to increase to the point where they started troubleshooting, but they got it turned back on the first and second time, but the third time only the neurologist could turn it on.

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 their neurologist last week and ¿got it straightened out.¿ the h ealthcare provider (hcp) advised them to gradually increase stimulation with current settings at ¿2.50 a 2.50,¿ but they hadn¿t been able to increase or decrease stimulation.During the call the consumer was asked what they saw on the screen when they couldn¿t adjust stimulation, but they didn¿t answer.It was reviewed how to increase stimulation and they confirmed they were able to increase the left side to 2.60, but they saw the ¿amplitude at upper limit¿ screen when they tried to increase the right side above2.50.The consumer was redirected to their hcp who said they would ¿probably¿ see their hcp this friday.The consumer mentioned this was actually the third time their implant had ¿shut itself down¿ in 5 years, with the first time about 3.5 years ago.The first time the implant turned off by itself, the patient thought they may have inadvertently turned it off with the programmer and confirmed they were able to turn it back on.The second time the consumer stated they were traveling out of state and didn¿t have the programmer with them so it wasn¿t until a week after traveling they discovered the implant was turned off.After the implant turned itself off for the second time, the consumer stated their neurologist had them see a neurosurgeon to see if the battery needed to be replaced who dete rmined it wasn¿t necessary.

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 a consumer reporting without any changes or "fiddling" with the patient programmer (pp), the dbs unit shut itself down.When they looked at the small number of task, they found it had been shut down and their patient programmer (pp) but could not turn it on.They followed the problem-solving tips in their manual but couldn't get it on.The third time was a major downer hitting at a time the patient really needed the therapy.There was no pre-shut down notice.Each time they realized, within a week there was a serious problem.The patient had lost some motor skills and some speech and had dystonia and freezing events.They also stated they don't if it was coincidence but the same week the unit turned itself off, their dystonia came raging back after 2 years absence.For 1.5 years before that they were on botox.Their neurologist has seen them four times in three months, adjusting the settings to reach to where they were before.They indicated the issue was resolved for now but they expect a fourth fai lure.When they saw their neurologist three weeks after the shutdown, the neurologist was surprised by the rapid changes in their speech and motion.When they last saw the neurologist 2 months ago, they brought a pair of tap shoes and demonstrated clogging (american step dancing) in the exam room.

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 a consumer who reported the implantable neurostimulator (ins) shut itself off for the 4th time in 6 years.Each time therapy had turned off, it took 4-5 days to discover the implant was off, and the most recent time they had gone ¿down hill¿ (symptom wise), so that¿s why they knew to check the implant.The consumer had turned the implant back on.It was unknown what caused the implant to turn off from either the consumer or their healthcare provider (hcp) as the hcp had checked the implant 2 days ago with their ¿tools¿ and told the consumer the data looked screwy.It was noted the data showed the implant was 100% in july of 2021 and 50% in august of 2021 which the consumer didn¿t agree with because they didn¿t let the implant battery go below 80% ever.The consumer was going to contact their hcp.

• 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: 11422494
• MDR Text Key: 234967804
• Report Number: 3004209178-2021-03764
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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,Followup,Followup,Followup
• Report Date: 09/27/2021

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: 10/14/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 03/08/2021; 03/20/2021; 05/03/2021; 09/19/2021
• Supplement Dates FDA Received: 03/15/2021; 03/24/2021; 05/06/2021; 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 77