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

Model Number 37612

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950)

Patient Problems Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2024

Event Type  malfunction  

Manufacturer Narrative

Section d information references the main component of the system.Other relevant device(s) are: product id: 37085-40, serial/lot #: (b)(6), ubd: 16-jun-2014, udi#: (b)(4) ; product id: 3389-40, serial/lot #: (b)(6), ubd: 17-mar-2014, udi#: (b)(4).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 reported a zapping sensation in her neck along the length of the extension location.The physician attempted to do a system integrity check but received an error message stating ¿system error - the system has encountered an unexpected error - please contact medtronic tech support¿.The dbs app was restarted and the same error occurred again.The local representative (rep) met with physician and interrogated the implantable neurostimulator (ins) with another clinician programmer.The same error occurred, code 0x51fdc908.Rep tried to connect multiple times and the same error occurred.Rep was able to interrogate the ins and use the programming functions but every time an impedance test was conducted the restart error occurred.Rep attempted to reset the ins three times but did not fix the issue.Another clinician programmer was used and the restart error occurred each time.The issue was not resolved.As the rep and physician were unable to run an impedance test, nodiagnostics were available.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

The patient has reported worsening of symptoms.Troubleshooting was not performed.The manufacturer representative (rep) wants to conduct impedance tests in different positions to look for an intermittent impedance issue that may result in temporary paresthesia being experienced that would be associated with sudden return of therapy.Manufacturer representative (rep) states they have had patients in the past describe this as a shocking sensation.The root cause of the issue has not been determined.The issue was resolved.In the set up, electrodes 8-15 were selected but no lead location was.Patient stated vague symptom of zapping sensation around the vicinity of the extension but not directly next to it.The neurologist did not believe it was related to the dbs but wanted to check impedances regardless.The patient only has one lead so i the additional one from the set up was cleared and everything was fine after that.It is suspected that this was set up with an 8840 clinician programmer and therefore remained incomplete as the 8840 didn't have to add all the details.The impedance issue was resolved by clearing the set up and reconfiguring.Impedance values were normal.Physician will meet with patient to adjust stimulation settings and was satisfied with the outcome.If the zapping sensation persists they will notify local rep.

Event Description

Additional information was received: it was reported that they ran impedances again using both the auto and fixed voltage at 3v.Additional information was received indicating that the patient had worsening of symptoms and wanted to know if/when they can test the impedances.

Manufacturer Narrative

Concomitant medical products: product id 37085-40, lot#/serial# (b)(6), implanted: (b)(6) 2010, product type extension product id 3389-40, lot#/serial# (b)(6), implanted: (b)(6) 2010, product type lead.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
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18807064
• MDR Text Key: 337622588
• Report Number: 3004209178-2024-05979
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2024
• Date Device Manufactured: 04/10/2018
• 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 H11...."
• Patient Sex: Female