MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC EXACTA DRAINAGE SYSTEM EVD COLLECTION SYSTEM; DEVICE MONITORING, INTRACRANIAL PRESSURE

Catalog Number 27666

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2019

Event Type  malfunction  

Event Description

One of the port on the evd was cracked.The port was cracked in the same spot as on another pt earlier in the week.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC EXACTA DRAINAGE SYSTEM EVD COLLECTION SYSTEM
• Type of Device: DEVICE MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC, INC. ; minneapolis MN 55432
• MDR Report Key: 8683384
• MDR Text Key: 147589385
• Report Number: MW5087218
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 27666
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR