MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)

Patient Problem Electric Shock (2554)

Event Date 02/27/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: the event date is an estimated date.Concomitant medical products: product id: 3708660, serial/lot #: (b)(4), ubd: 23-oct-2022, udi#: (b)(4).Product id: 3387s-40, serial/lot #: (b)(4), ubd: 11-oct-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported they started getting "shocked" and "zapped" after the surgeon "turned on the second half of my wires in my brain in 2019".The patient stated that they would always feel the stimulation but if they would press on their head, "all of a sudden i will get shocked and it'll be so bad that it'll make me grab my chest and people think i'm having a heart attack".They spoke with a manufacturer representative (rep) today regarding this and they have been speaking with the physician and neurologist.They are doing their best to assist the patient in resolving this under the current covid circumstances.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative (rep).It was reported due to the covid-19 circumstances, no actions/troubleshooting will be done until further notice and the cause of the shocking will not be able to be determined until clinic appointments are scheduled, which could be months before the patient is seen.

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

Continuation of d10: product id 3708660 lot# serial# (b)(6), implanted: (b)(6) 2019, explanted: product type extension product id 3387s-40 lot# va1xbzh serial# implanted: (b)(6)2019,explanted: 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.

Event Description

Additional information was received.Patient re-reported events and referred to the sensation as "getting voltage charges from the battery." patient stated that the "zapping" sensation has become frustrating and is getting painful.Her provider thinks it might be an issue with the lead, noting that they think something might be loose or not registering.Patient said she thinks it might be related to movement or muscle.The managing provider can't find anything wrong with the implanted neurostimulator when they do diagnostics.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 9943343
• MDR Text Key: 187082783
• Report Number: 3004209178-2020-06957
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/25/2020

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 Expiration Date: 04/14/2012
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/07/2020
• Initial Date FDA Received: 04/09/2020
• Supplement Dates Manufacturer Received: 04/09/2020; 10/08/2020; 11/23/2020
• Supplement Dates FDA Received: 04/10/2020; 10/08/2020; 11/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 94