MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problem Failure to Deliver Energy (1211)

Patient Problems Seizures (2063); Convulsion/Seizure (4406)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient was admitted to their hospital from experiencing seizures following their implantable neurostimulator (ins) switching off.The ins was switched back on and the patient stabilized and went home.They were asked if the ins could be switched off using the buttons on the side of the recharger but it was told it was not possible since the feature was disabled in the ins'.Session reports were asked to be obtained for cause, but they hadn't been stored in the n'vision.The patient's parents were experienced in recharged the patient's battery and had been doing so for a number of years.When they were admitted they were being cared for at a care home and questions were asked if the people who care for the patient had recharged the battery sufficiently.Since returning home the ins had switched off once again.They were able to switch the device back on using the programmer.The issue was not resolved.

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 indicating the patient has been getting charged during their sleep as they could not tolerate the recharging when awake.

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: it was reported that the rep had reviewed the session reports with the nurse.They said the battery status on the tablet, recharger, and patient programmer all reported low/25% battery levels.The father of the patient said the device had switched off twice since the last interrogation by the nurses.The correct recharging process was reviewed with the father and they seemed competent, although there was some misunderstanding about the use of the patient programmer and the nurse clarified some symbols.The patient was stated to having learning and behavioral issues which made the compliance with recharging problematic, and sometimes the patient wouldn't allow the father to charge at all.As the patient was set at 5v bilaterally it was potentially an issue as therapy wouldn't be able to be delivered.They managed to get the recharge level to 50% before the patient became restless and the parents were going to try to get the charge up to at least 75% when they returned home.The ins was implanted in the abdomen so they would try to get a waist belt to help with recharging.Additional information was received: it was reported that after checking charging statistics there was no por, and emi could be ruled out as a potential cause.Recharge coupling was excellent but the charging sessions were often limited in time and the ins only charged to a limited percentage.There was therapy loss on (b)(6) 2020, (b)(6) 2020, and (b)(6) 2020.It was also seen that therapy was restored on (b)(6) 2020, which coincided with the recharging session.Given the high settings of the ins and limited recharging the cause of the loss of therapy was believed to be due to the ins being insufficiently charged to provide the required therapy, resulting in depletion.There was therapy loss on (b)(6) 2020 that was restored after charging on (b)(6) 2020.

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 NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 10824062
• MDR Text Key: 217325144
• Report Number: 2182207-2020-01261
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization