MAUDE Adverse Event Report: ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number 37612

Device Problems Unintended Collision (1429); Low impedance (2285); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2021

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), ubd: 24-may-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported there was low impedance between contact 9 and 10.The patient had fallen several times, which may have contributed to the issue.No troubleshooting was performed.The issue was not resolved at the time of the report.Additional information was received indicating the cause of the issue was due to the patient falls and their care.There was an issue with the extension as it was defective and the extension was replaced.After the replacement, all of the impedances were within normal range.

Event Description

Additional information was received: it was reported that they believed the extension was damaged.

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id 3708660 lot# serial# (b)(6) explanted: (b)(6)2021 product type extension product id 3389-28 lot# unknown serial# implanted: 2019-09-12 product type lead product id 3708660 lot# serial# (b)(6) explanted: (b)(6)2021 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.

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id: 3708660, serial# (b)(6), explanted: (b)(6) 2021, product type: extension; 3708660, serial# (b)(6), explanted: (b)(6) 2021, product type: extension.H3: analysis of the extension could not be performed as patient consent for analysis was not received.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 PARKINS
• MDR Report Key: 12294658
• MDR Text Key: 265610063
• Report Number: 2182207-2021-01378
• 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
• Report Date: 11/01/2021

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 Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 08/10/2021; 11/01/2021
• Supplement Dates FDA Received: 08/13/2021; 11/01/2021
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention