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); Pain (1994); Impaired Healing (2378); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	03/15/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Medtronic received information regarding a device used for cranial repair.It was reported that a patient with history of myelomeningocele and tethered spinal cord who underwent a tethered cord release with patch duraplasty using intraoperative ultrasound and operating microscope almost a year ago, which was complicated by a symptomatic pseudomeningocele requiring re-exploration and cerebrospinal fluid (csf) leak repair, as well as recurrent csf leak requiring re-exploration, ventriculoperitoneal shunt placement and complex plastic surgery closure, whose course was also complicated by dehiscence of the shunt incision which required shunt removal.Most recently, the patient had another delayed re-accumulation of a pseudomeningocele which caused back and leg pain, for which the site admitted them to the hospital and performed a lumbar wound tap, external ventricular drain (evd) placement, confirmed cultures negative, and placed a left ventriculoperitoneal shunt.After these procedures, the patient was ambulatory without back or leg pain.They were eventually discharged in fairly good condition and had been at home.Since then their back pain has reoccurred, and they were also experiencing left lower extremity spasms and pain.They were keeping their symptoms when they experienced a symptomatic pseudomeningocele.The patient therefore underwent an mri which the site was here to review today.In the past, we had been somewhat concerned about a particular dural patch that was utilized in their back, which was since removed from the shelf from the manufacturer.We had been uncertain as to whether this had been causing their issues or not given the extremely complicated course with poor healing and a persistent and symptomatic pseudomeningocele and presumed csf leak despite shunting and multiple explorations and drainage.
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: 18968451
• Report Number: 2021898-2024-00076
• Device Sequence Number: 6807416
• 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: 09/30/2024
• Device Model Number: 62110
• Device Catalogue Number: 62110
• Device Lot Number: 2207049
• 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: 11/28/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 77 KG