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

Model Number 37612

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

Patient Problems Bacterial Infection (1735); Headache (1880); Convulsion/Seizure (4406); Swelling/ Edema (4577)

Event Date 08/09/2023

Event Type  Injury  

Manufacturer Narrative

Section d references the main component of the system.Other medical products in use during the event include: brand name sensight; product id b3300542 serial: (b)(6); product type: 0200-lead; implant date (b)(6) 2023; explant date brand name sensight; product id b3300542m serial: (b)(6); product type: 0200-lead; implant date (b)(6) 2023 explant date brand name sensight; product id b3400060m serial: (b)(6); product type: 0191-extension; implant date (b)(6) 2023; explant date 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 the patient convulsed/had seizures and severe headaches.The patient was hospitalized because of the incident.They performed a tomography where they showed the patient had cerebral edema around the electrodes.For now they hadn't explored ac tions/interventions but would be carrying out tests the next day for the final diagnosis.They would send one of the two electrodes to culture at the institution.The electrodes would be explanted and one will be sent for review.The issue was not resolved, but more information would be gathered august 25, 2023.

Event Description

Additional information was received from a manufacturer representative (rep) reporting that the electrodes were explored on aug-11th.Staphylococcus aureus was in the electrode culture.

Manufacturer Narrative

Section d information references the main component of the system.Other relevant device(s) are: product id b3300542, serial# (b)(6), implanted: (b)(6) 2023, explanted: (b)(6) 2023, product type lead.Product id b3300542m, serial# (b)(6), implanted: (b)(6) 2023, explanted: (b)(6) 2023, product type lead.Product id b3400060m , serial# (b)(6), implanted: (b)(6) 2023, product type extension.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 PARKINS
• 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: 17510038
• MDR Text Key: 320884270
• Report Number: 3004209178-2023-14148
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2023
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 08/11/2023
• Supplement Dates Manufacturer Received: 08/15/2023
• Supplement Dates FDA Received: 08/23/2023
• Date Device Manufactured: 02/03/2023
• 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 Outcome(s): Hospitalization
• Patient Age: 47 YR
• Patient Sex: Male