MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DUREPAIR DURA SUBSTITUTE

Model Number UNKNOWN-D

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was an allergy-infection in a patient that had the item put in on (b)(6) 2020.

• Brand Name: DUREPAIR DURA SUBSTITUTE
• Type of Device: 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 10116367
• MDR Text Key: 193741130
• Report Number: 2021898-2020-00160
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-D
• Device Catalogue Number: UNKNOWN-D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2020
• 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): Other