MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number 37612

Device Problems Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586)

Patient Problems Fatigue (1849); Pain (1994); Electric Shock (2554); Insufficient Information (4580)

Event Date 03/20/2022

Event Type  malfunction  

Event Description

It was reported that the patient complained of transient shocking sensations around their implantable neurostimulator ins. the patient did not recall any event that coincided with the start of these sensations.This has been a recurring issue since the spring of 2022. the patient said their doctor was already aware of the problem, and they mentioned that they had seen multiple doctors about this issue.The patient said their doctor had done ultrasounds and x-rays, but they did not provide the results.See rtg0404825, rtg0404968, and mpxr #1031207 for previous reports of shocking sensations. the patient said the shocking sensation was like a small voltage, but it hurt.The patient described it as "getting poked with six pins all at once." the patient said sometimes, the shocking sensation occurs when they pick up their purse, bend over, or stand up, or after they are done working around the house, and they don't do a lot because they are very disabled.The patient also mentioned that the other day, the shocking sensation was so bad that they could not stand it, and they had to hold onto the ins battery so it didn't move (the patient said the ins battery moves in the pocket). the patient said they had not had a shock this morning, but they were in the er for 3 hours the other day because they thought they were having a heart attack.The er determined nothing was wrong with the patient.While in the er, they noticed that they only experienced the shocking sensation when the ins was turned on.The patient did not experience any falls/trauma before this event. the patient called their doctor at 2:00 am because they felt tired and crappy.The patient also reported an issue with the ins charging slowly.The patient said they charged for 7 hours the night before, but the battery level did not increment past 25%, and their patient programmer (pp) kept indicating that the ins charge level was low.During the call, the agent had the patient start a charging session, and they initially had four coupling bars filled in.The agent had the patient rotate the antenna dial one-quarter turn c lockwise, and then the patient got all eight coupling bars to fill in.The agent reviewed that there did not appear to be an issue with the recharger.The patient was redirected to their healthcare provider to address the matter further.Additional information was received from the manufacturer representative (rep) on 2023-sep-06 that the patient had the dbs system imaged to inspect for damage.None was identified. additionally, the patient has seen multiple providers, and none have been able to determine the cause.

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.

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

Additional information received from the consumer reported nothing was done to resolve the shocking sensation and implant movement and thus the issue wasn¿t resolved.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• 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: 17696084
• MDR Text Key: 322814650
• Report Number: 3004209178-2023-15477
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2023
• Date Device Manufactured: 01/29/2016
• 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 Age: 59 YR
• Patient Sex: Female
• Patient Weight: 104 KG