MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DUREPAIR®; DURA SUBSTITUTE

Model Number	62105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information regarding a durepair.The patient had a preexisting characteristic of pneumonia.The patient had a durepair device implanted on an unknown date.The product was recalled and the site became aware of the recall on an unknown date.The product was removed from their inventory and the healthcare professional were made aware.The patient developed symptoms of acute inflammatory process, comparable to infection.Leukocytosis noted on an unknown date.Infectious disease was consulted.Wbc's trended up with the highest being 44.1 on an unknown date.The patient was thought to be having a reaction to endotoxin levels from the device that was implanted on an unknown date.The procedure was craniectomy for excision of tumor.
Additional Manufacturer Narrative
H3, h6: no products have been returned to medtronic for analysis.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.
Additional Manufacturer Narrative
H2: see b5.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 or Problem Description
Additional information was received.Durepair implanted (b)(6) 2023 and was not explanted.Day of surgery wbc 12.2 and continued to trend up.(b)(6) 2023 ancef ordered.(b)(6) 2023 wbc 15.6, febrile max temp.101.7.(b)(6) 2023 wbc 26.5, febrile max temp.100.6.(b)(6) 2023 wbc 44.1, febrile max temp.100.2.(b)(6) 2023 wbc 25.6 febrile max temp.101.3- chest xray hazy bibasilar infiltrates , vancomycin ordered wbcs came down.Continued with bibasilar pna.Discharged to snf.

• Brand Name: DUREPAIR®
• Common Device Name: DURA SUBSTITUTE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17435171
• Report Number: 2021898-2023-00050
• Device Sequence Number: 18345813
• Product Code: GXQ
• UDI-Device Identifier: 00643169063860
• UDI-Public: 00643169063860
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: 62105
• Device Catalogue Number: 62105
• Device Lot Number: 2203031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 73 KG