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

Model Number 37603

Device Problems Display or Visual Feedback Problem (1184); Energy Output Problem (1431); Loss of Power (1475); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2018

Event Type  malfunction  

Manufacturer Narrative

Event date is approximate.Month and year valid.See regulatory report # 3004209178-2018-16305 for other implantable neurostimulator involved in this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins) for the treatment of movement disorders.It was reported there was an out of regulation (oor) message on the patient programmer (pp) beginning three days prior.It was reported the patient's mom had been seeing oor on the right side and on the day of the call it was on the left side also.The tablet was not reading oor and neither was the old clinician programmer (8840).The therapy impedance was 884 on the right side.Historical impedances from 2016 were: 84, 849, 1121, 846, 906, 1202, and 937.The left side therapy impedance was 1072.Historical impedances from 2016 were: 111, 1121, 1765, 1138, 1205, 914, 1265, 1072.It was reported they did not have electrode impedances to check against but on the day of the call the right was 870-1200 and the left was 1900-2500.The patient was programmed in constant current mode.The caller added that the patient had a change in therapy beginning 8 days prior and was presenting differently with an increase in ticks.The health care professional (hcp) added that could be brought on by stress with this patient as well.The ins battery levels were 2.91 and 2.89.The caller indicated the patient's settings had been stable since (b)(6) 2017.No falls or trauma were reported.The caller added that the ticks had been worsening over the past 2 days.It was reviewed that checking frequently with the pp can cause an oor message.The caller did not think this was happing.The caller stated that the patient shut the pp down in between checking sides.The batteries in the pp were changed on the day of the call.It was reported there was no correlation between position/activity and the oor message.It was observed on the day of the call when the patient was lying flat on the table.The patient was not increasing or decreasing when this happened as they did not have that option.It was reported the devices were in the patient's abdomen.The caller read with her 8840 on the call and the impedance values were the same with no oor.After reading, they went back to the pp and neither side was displaying an oor.The option to put the patient on constant voltage to see if that resolved the issue was overturned as it was notan ideal option.It was recommended the patient use a different patient programmer and stop checking the device multiple times and powering it down in between.It was suggested that the electrode impedances were kept on file for comparison.No further complications were reported or anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

Product event summary #investigation summary - it was reported that the patient programmer showed an oor message but the clinician tablet and clinician programmer (8840) did not show oor and the patient had a sudden change in therapy.As the event was reportable to a regulatory authority and indicated a possible failure of a device, labeling, or packaging to meet any of its specifications, an investigation was required.Additional information was required to determine the cause of the event.The rep, hcp, and patient were contacted to determine the cause of the issue, the troubleshooting done, and the outcome of troubleshooting.No additional information was received.As the device was still in use at the time this investigation was completed, no analysis could be performed.There was no indication that the event was related to a possible manufacturing issue, so a device history record review was not performed.The investigation determined that there was insufficient information to determine the cause of the event.The cause of the oor and change in therapy was not reported to the manufacturer, and was unable to be obtained through follow-up requests.Should additional information become available at a later date, the investigation will be re-opened and updated accordingly.Continuation of d11: product id 37603, serial# (b)(6), implanted: (b)(6) 2018, explanted: product type implantable neurostimulator 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

Devices were returned for disposal.

Manufacturer Narrative

Product analysis #253129963:analysis information -- (b)(6) 2020 08:30:22 cst pli# 20 product id# 37603 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The implantable neurostimulator (ins) passed functional testing.Continuation of d11: product id 37603 lot# serial# (b)(6) impl anted: 2018-(b)(6) explanted: product type implantable neurostimulator 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

Product event summary, investigation summary - it was reported that the patient programmer showed an oor message but the clinician tablet and clinician programmer (8840) did not show oor and the patient had a sudden change in therapy.As the event was reportable to a regulatory authority and indicated a possible failure of a device, labeling, or packaging to meet any of its specifications, an investigation was required.Additional information was required to determine the cause of the event.The rep, hcp, and patient were contacted to determine the cause of the issue, the troubleshooting done, and the outcome of troubleshooting.No additional information was received.As the device was still in use at the time this investigation was completed, no analysis could be performed.There was no indication that the event was related to a possible manufacturing issue, so a device history record review was not performed.The investigation determined that there was insufficient information to determine the cause of the event.The cause of the oor and change in therapy was not reported to the manufacturer, and was unable to be obtained through follow-up requests.Should additional information become available at a later date, the investigation will be re-opened and updated accordingly.Product analysis #(b)(4): analysis information -- on 07/09/2020 08:30:22 cst pli# (b)(4) product id# 37603.Below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The implantable neurostimulator (ins) passed functional testing.Continuation of d11: product id: 37603, serial# (b)(6), implanted: (b)(6) 2018, product type: implantable neurostimulator.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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7706588
• MDR Text Key: 115087626
• Report Number: 3004209178-2018-16306
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864214
• UDI-Public: 00643169864214
• 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,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/16/2020

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: 07/28/2019
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2020
• Initial Date Manufacturer Received: 07/18/2018
• Initial Date FDA Received: 07/20/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 05/01/2020; 07/09/2020; 09/16/2020
• Supplement Dates FDA Received: 10/04/2018; 05/04/2020; 07/10/2020; 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 19 YR