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 Codes	Bacterial Infection (1735); Muscle Weakness/Atrophy (1967); Seizures (2063); Complaint, Ill-Defined (2331)
Date of Event	03/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please see report number (b)(4) submitted in jan 2018.If information is provided in the future, a supplemental report will be issued.(b)(4).
Event or Problem Description
It was reported that the patient had a meningioma removed and subsequently, had an infection "(b)(6)", which required two additional procedures.The patient was concerned about the 2 infections that she developed 20 days post-surgery.It was noted that the patient was told by infection control that this was likely acquired during the first surgery and was the reason for the delayed symptoms included the infector needing to grow from the inside before showing outward symptoms.The patient was concerned that the bovine membrane implant was contaminated, or that somehow during the surgery, she acquired two different bacteria that cause the infection.The original intended procedure was a stealth-guided craniotomy for gross total excision of a tumor and surrounding dura with excision of inner table of involved bone with resection and hemostasis down with operating microscope.
Additional Manufacturer Narrative
(b)(6).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from a health care provider (hcp).It was reported that the evidence of infection presented itself to the patient so she scheduled an appointment to have the bone flap removed and start a broad-spectrum of antibiotics.The patient's symptoms included right arm weakness and the patient thought she may have had a mild seizure.The patient is currently recovering from the infection.There were no external factors that were recorded as a potential influence.

• Brand Name: DUREPAIR®
• Common Device Name: DURA SUBSTITUTE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7280101
• Report Number: 2021898-2018-00096
• Device Sequence Number: 13756177
• Product Code: GXQ
• UDI-Device Identifier: 00643169063860
• UDI-Public: 00643169063860
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K041000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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: 05/31/2019
• Device Model Number: 62105
• Device Catalogue Number: 62105
• Device Lot Number: 1608002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2018
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 02/19/2018
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR