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

Model Number 37603

Device Problems Display or Visual Feedback Problem (1184); Failure to Power Up (1476); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2022

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are: product id: 37642, serial/lot #: njz141177n, ubd: , 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 patient (pt) noticed their essential tremor was not doing good.Patient services (pss) did not ask about the c ircumstances that led to the reported issue, but the patient mentioned that their patient programmer stopped working a couple of months ago, which they used to turn therapy off and night and back on in the morning.The patient explained that the patient programmer would make a beeping sound when they pressed the power button, but the patient programmer did not power on (the display remained dark/blank).Pss asked the patient if it felt like therapy was turned off at the time they felt like their essential tremor was not doing good, but the patient recalls turning therapy on in the morning prior to the issue with the patient programmer (the patient said they knew they turned therapy on that morning because they could feel the stimulation down both sides of their body).The patient stated that they inserted brand-new aaa batteries into the patient programmer, but the issue persisted.As a result, they were unable to check if therapy was turned on.The patient stated that they met with their neurologist today and they told the patient that the rapy was turned on for each ins.The patient stated that their neurologist "upped" the stimulation today, and told the patient to get the patient programmer replaced so they could resume turning therapy off at night and back on in the morning to see if that would help with the essential tremor.The patient also mentioned that their neurologist plans on setting up adjustable parameters on the patient programmer at their next appointment in 3 months.An email was sent to repair to replace the patient programmer, and the patient was redirected to their healthcare provider to further address the essential tremor.

Manufacturer Narrative

H3.Analysis of the patient programmer (s/n (b)(6) found the digital board was corroded.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 ESSENTI
• 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: 15335527
• MDR Text Key: 305423591
• Report Number: 3004209178-2022-11229
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00763000100353
• UDI-Public: 00763000100353
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2020
• 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 Age: 69 YR
• Patient Sex: Female