MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DUET EXTERNAL DRAINAGE AND MONITORING SYSTEM; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number	46913
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that when the patient's evd catheter was attached in the operation room, it was discovered that the stopcock was obstructed and was not flowing properly through the stopcock regardless of the orientation.The system was replaced and it was confirmed the second unit was working fine.There was a very small delay in surgery while the replaced the system; however, there was no patient impact.
Additional Manufacturer Narrative
The returned device was patent.Therefore, the conditions of the complaint could not be duplicated by laboratory personnel.It met the requirements for leak testing.All edms devices are 100% leak tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DUET EXTERNAL DRAINAGE AND MONITORING SYSTEM
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7258840
• Report Number: 2021898-2018-00075
• Device Sequence Number: 987345
• Product Code: GWM
• UDI-Device Identifier: 00613994445360
• UDI-Public: 00613994445360
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K802100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

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: 06/30/2020
• Device Model Number: 46913
• Device Catalogue Number: 46913
• Device Lot Number: 213607607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 04/03/2018
• 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