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

Model Number 37601

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Fever (1858); Headache (1880); Unspecified Infection (1930); Muscle Spasm(s) (1966); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); Swelling (2091); Burning Sensation (2146); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517); Cognitive Changes (2551); Confusion/ Disorientation (2553)

Event Date 10/15/2019

Event Type  Injury  

Manufacturer Narrative

Correction: for report source and added in country.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Concomitant medical products: product id neu_unknown_ext, serial#: unknown, product type: extension.Product id: neu _unknown_lead, serial#: unknown, product type: lead.Other relevant device(s) are: product id: neu_unknown_ext, serial/lot #: unknown.Product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by the patient that after the device was implanted the patient felt like they were misplaced, uneasy, confusion, couldn't concentrate, and her brain felt like it was swelling and with the feeling of anesthesia.They had a headache (parietal right), hallucinations, sleep problems, pain on the injury of the mark of stereotaxic and where the extensions passed and on the device pocket.They developed an infection (she had fever, pain, and redness).Due to that and after the receiving the result of the lab test (c reactive protein), they were admitted to the hospital.After the device was withdrawn, they still had pain on the unspecified areas where they had unspecified injuries.Environmental/external/patient factors include the student physicians that used the mark of stereotaxic, they did not use any type of anesthesia and they did the procedure on the corridor of the hospital.Patient reported a bacterial infection due to (b)(6).On (b)(6) 2019, a surgery was performed because the device needed to be fully withdrawn.The issue is not yet resolved.Patient symptoms included an altered mental status, headache, and an infection.A blood culture was taken.Antibiotics were given.Date of onset/diagnosis of infection was (b)(6) 2019, c-reactive protein was at (b)(6).Pain was located at the device pocket, extension location, and lead location.The surgical intervention included removing all the device symptoms.The patient was in the hospital for approximately 14 days with the antibiotics (cefalexina and vancomicina).

Event Description

Additional information was received stating that the patient reported after surgery that she felt her spine would fall apart and disabling pains.As treatment for the pain, she took stalevo and the pain relieved one hour after.

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

Section d information references the main component of the system and other applicable components are: : product id neu_unknown_ext lot# serial# unknown implanted: explanted: product type extension product id neu_unknown_lead lot# serial# unknown implanted: 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 from the patient stating that after the surgery, patient had stronger pain and muscle contractures and "neurological pain".The "neurological pain" is stronger at night and as treatment for that she takes gabapentin, metamizole, tramadol or acetaminophen (the drug that she takes depends, because these drugs give her headache or dyskinesias or dithonias on her feet).Also, when she has headaches, she experienced like her head growing up (as reported) because the scars stretch, and it results in pain and burning scalp.During the night she experienced the same, pain and burning on the scar of the clavicle and burning on her legs and the right side of her body, which causes intense pain too.Patient medical treatment is: stalevo (levodopa, carbidopa, entacapone 100/25/250) and amantadine.

Event Description

Additional information was received from the manufacturer representative (rep) reporting that it was an inflammatory reaction and infection.No hallucinations or other symptoms were reported.The medical record at the day of explant states consciousness.Actions/interventions included the surgery for explant on (b)(6) 2019.They were admitted through the emergency room.50cc of purulent fluid was collected in the right side torax under implant of the generator.This was confirmed with the physician.All devices were discarded per hospital policy.

Manufacturer Narrative

Update of the continuation of d11: product id: 3708660, serial# (b)(6), implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: extension.Product id: 3389-40, lot# 0217643847, implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: lead.Product id: 3708660, serial# (b)(6), implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: extension.Product id: 3389-40, lot# 0218273916, implanted: (b)(6) 2019, explanted: (b)(6) 2019, 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 PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• MDR Report Key: 10181926
• MDR Text Key: 199278673
• Report Number: 2182207-2020-00398
• Device Sequence Number: 1
• Product Code: MHY
• 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,Followup,Followup,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."; SEE H10....
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR