MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DUET EDMS, SMARTSITE WITH NEEDLELESS INJECTION SITES; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Catalog Number	46914
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned product was found to be not patent.It also met the requirements for leak testing.The patient line was found to be occluded at the junction of the patient line stopcock.All edms devices are 100% leak tested at the time of manufacture.
Event or Problem Description
It was reported to medtronic neurosurgery that the patient line stopcock was not working.According to the report, nothing would move when the stopcock was in the ¿on¿ position.Reportedly, the product failed during set-up and there was no injury to the patient.

• Brand Name: DUET EDMS, SMARTSITE WITH NEEDLELESS INJECTION SITES
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6426501
• Report Number: 2021898-2017-00122
• Device Sequence Number: 1102276
• Product Code: GWM
• UDI-Device Identifier: 00613994445377
• UDI-Public: 00613994445377
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K802100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 46914
• Device Lot Number: 212214004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2017
• Initial Report FDA Received Date: 03/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1