MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF ULTRA SMALL VALVE, MEDIUM PRESSURE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	42414
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	01/02/2018
Type of Reportable Event	Malfunction
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 valve was connected to the ventricular catheter during the procedure, the flow of cerebrospinal fluid could not be seen, despite manual pumping.The physician determined that the valve did not work and replaced it with another manufacturer¿s valve.The patient¿s status was noted as ¿okay/fine.¿.

• Brand Name: CSF ULTRA SMALL VALVE, MEDIUM PRESSURE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7244770
• Report Number: 2021898-2018-00066
• Device Sequence Number: 10804302
• Product Code: JXG
• UDI-Device Identifier: 00643169466081
• UDI-Public: 00643169466081
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K873247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2018

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: 12/31/2019
• Device Model Number: 42414
• Device Catalogue Number: 42414
• Device Lot Number: D73699
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 YR