MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Delayed Charge Time (2586); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Additional information was received: it was reported that the cause of the oor message was unknown.

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for dystonia, movement disorders.It was reported that the caller stated they saw an oor message appear twice.The first time was 2 weeks ago, and it went away.The second time was last week.The error was cleared when the caller read the patient¿s device with the clinician programmer and there were no complaints with symptoms.The caller ran impedances and all the numbers looked fine.It was also reported that the patient¿s device was dropping faster.They used to charge once a week on friday¿s and charge to 100%.The caller stated they recharged for 52 minutes and the ins went from 25%-50% with 7 coupling bars.The patient recalled charging for 2 hours and it only went to 75%.The caller stated the patient had a change in parameters in september amplitude increased by.2v and frequency increased by 80-100 hz but didn¿t believe that it would have that large of an impact.The last time they charged to 100% was a month ago.It was reviewed that insr records showed last 6 recharge sessions and were told to charge to 100% going forward.There were no further complications reported.

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 doctors were aware of the cleared oor.Additional information was received stating that the patient¿s father texted the rep and said they noted an oor message on the patient programmer.No troubleshooting was done but the rep may go meet with the patient on monday (b)(6) 2019.There were no out of range impedances reported and the oor wasn¿t 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 from the manufacturer representative (rep).The rep reported that patient had seen an oor message on the patient programmer (pp).The patient/their mom did not recall what position the patient was in when the oor message occurred.It was stated that when the patient is in oor, they feel uncomfortable and has some movement that indicates patient is uncomfortable.It was noted that the patient has ins implanted on the right side belly.Electrode impedance tested at 3v on the tablet: c0: 869 ohms c1: 1248 ohms c2: 1156 ohms c3: 878 ohms 01: 1816 ohms 02: 1925 ohms 03: 1727 ohms 12: 1971 ohms 13: 1759 ohms 23: 1603 ohms left side c8: 1040 ohms c9: 1099 ohms c10: 1391 ohms c11: 1650 ohms 8/9:1558 ohms 8/10: 2231 ohms 8/11: 2599 ohms 9/10: 1768 ohms 9/11: 2315 ohms 10/11: 2053 ohms it was reported that patient was programmed group a right.3+1-2- 4.2v/120pw/100hz.Therapy impedance: 1130 ohms and 3.7ma left c+9- 4.3v/90pw/100hz.Therapy impedance: 1117 ohms and 3.9ma it also mentioned that electrode impedances were tested when the patient laid on their right side and the impedances were unchanged.The rep did not see any alerts when they interrogated or on the reports.Recharging statistics were obtained and reviewed.No out of range impedances were reported.The oor was cleared by the conclusion of the call.

Event Description

Additional information was received: it was reported that the oor was cleared however the cause was unknown.The parent was unsure if the recharging times were longer.As recommended, they called in and said to charge till 100% the next 6 charging sessions.They charged once a week so it would take 6 weeks.

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.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 9215196
• MDR Text Key: 184580929
• Report Number: 3004209178-2019-20045
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/07/2020

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: 11/28/2018
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 10/21/2019; 12/01/2019; 12/17/2019; 12/26/2019; 10/07/2020
• Supplement Dates FDA Received: 11/07/2019; 12/06/2019; 12/26/2019; 01/09/2020; 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 10 YR