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

Model Number	62110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Headache (1880); Pain (1994); Discomfort (2330)
Date of Event	05/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information regarding a device used for cranial repair.It was reported that a patient did well for some time after a tethered cord release with expansile patch duraplasty and intraoperative ultrasound but developed a delayed pseudomeningocele for which the site performed a ventriculoperitoneal (vp) shunt exploration which was found to be functional, as well as a lumbar wound exploration, and cerebrospinal fluid (csf) leak repair with revision duraplasty due to a concern for an issue with the dural substitute patch which was confirmed with a complex plastic surgery closure.Patient did extremely well from this operation, and had been at home.Visiting the site today was the patient's first time leaving their house since surgery.Overall they were doing quite well.Preoperatively, they were experiencing significant headaches which had since completely resolved.Patient was also experiencing significant back pain with tenderness to touch of their back due to a large pseudomeningocele that was present but contained within the skin.This was also improved significantly since surgery, and they were essentially pain-free.The patient did not have any radicular pain, and was overall doing well.They will be following up with plastic surgery as well.All of their drains had been removed and the wound vac was also.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18969199
• Report Number: 2021898-2024-00077
• Device Sequence Number: 6639274
• Product Code: GXQ
• UDI-Device Identifier: 00643169063884
• UDI-Public: 00643169063884
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K063117
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: 62110
• Device Catalogue Number: 62110
• Device Lot Number: 2207020
• 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: 03/21/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 03/28/2024
• Date Device Manufactured: 10/07/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2207-2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 77 KG