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

Model Number 37601

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Nausea (1970); Pain (1994); Numbness (2415); Ambulation Difficulties (2544); Electric Shock (2554); Weight Changes (2607); Paresthesia (4421); Insufficient Information (4580)

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient complains of feeling electric zaps throughout various parts of her body, which she feels all the time.When she gets ¿startled¿ with someone entering the room when she wasn¿t expecting it or other scenerios like this, her ¿zaps¿ intensify.She also feels pains in her legs (tingling).She has also experienced ¿balance¿ issues that she says were not there before dbs.When she bends at the waist and lowers her head, she can feel nausea and gets numbness and tingling sensations across her head.She complains of her head hurting in that it is very sensitive to touch so brushing her hair is bothersome as well as washing her hair. she has gained a considerable amount of weight, partially due to not having any tremor anymore.She also ¿twisted¿ her ankle awhile back which caused her to have limited mobility for some time. electrode impedance was assessed many times since implant and there has never been an issue.The patient decided to turn her deep brain stimulation (dbs) therapy off to see if any of the ¿zaps¿ would subside. she called the rep after to say that the ¿zaps¿ and painful touching feeling on her head subsided significantly within minutes afterward.She also felt more stable with her balance.She is going to wait overnight and let me know in the morning how she feels.Her tremor returned within seconds and was significant but she is going to leave it off until tomorrow to assess the difference.The issue was not resolved.

Manufacturer Narrative

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

The cause was unknown.They are going to attempt to reprogram to resolve the issue.

• 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
• MDR Report Key: 11886572
• MDR Text Key: 267306829
• Report Number: 3004209178-2021-08382
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00643169864191
• UDI-Public: 00643169864191
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR