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

Model Number 37601

Device Problems Break (1069); Low impedance (2285); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 12/20/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products.Other relevant device(s) are: product id: 3389-28, serial/lot #: unknown.Product id: 37085, serial/lot #: unknown.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

It was reported that the patient experienced a trauma with unknown cause at a location near the extension cables.After that, their parkinson's symptoms increased.Right subthalamic nucleus (stn) bipolar impedances were shown to be abnormally low in a following impedance test.The trauma may have led to damage of the extensions, connectors, lead cables or misplacement of the right hemisphere lead (unlikely).The neurologist has checked the symptoms, ran impedance test, and the patient has received treatment for the trauma and is recovering from the trauma.X-ray was suggested to find potential rupture or disconnection.The dbs stimulation has been changed from bipolar to unipolar.The issue has not been resolved.Explant of the extension is planned.

Manufacturer Narrative

Continuation of d10: product id 3389-28 lot# unknown serial# implanted: explanted: product type lead product id 37085 lot# serial# unknown implanted: explanted: product type extension.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 there were no x-ray's taken.After reprogramming the patient's stimulation to avoid using the contact with out of range impedances there were no further problems and the patient recovered.It had been decided to leave the system as is until the battery would need to be replaced.At that time the system would be revised.

Event Description

It was reported that the patient experienced a trauma with unknown cause at a location near the extension cables.After that, their parkinson's symptoms increased.Right subthalamic nucleus (stn) bipolar impedances were shown to be abnormally low in a following impedance test.The trauma may have led to damage of the extensions, connectors, lead cables or misplacement of the right hemisphere lead (unlikely).The neurologist has checked the symptoms, ran impedance test, and the patient has received treatment for the trauma and is recovering from the trauma.X-ray was suggested to find potential rupture or disconnection.The dbs stimulation has been changed from bipolar to unipolar.The issue has not been resolved.Explant of the extension is planned.Additional information was received reporting that it seemed like the patient's dbs hardware was malfunctioning because they were getting low impedances.Additional information was received from a manufacturer representative (rep) reporting that the cause was not determined.A trauma is suspected to have damaged a cable.The patient has been scheduled to undergo revision surgery.Additional information was received: it was reported that there were no x-ray's taken.After reprogramming the patient's stimulation to avoid using the contact with out of range impedances there were no further problems and the patient recovered.It had been decided to leave the system as is until the battery would need to be replaced.At that time the system would be revised.

Manufacturer Narrative

Additional review indicates that information from manufacturer¿s report #2182207-2022-02404 was already reported in this report (#21 82207-2022-02388).Any additional information regarding this event will be submitted as a supplemental submission to this report.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
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16040928
• MDR Text Key: 306066567
• Report Number: 2182207-2022-02388
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2023
• 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 Outcome(s): Required Intervention
• Patient Sex: Male