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

Model Number	22011 M
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	11/01/2018
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 while testing the valve during the procedure, the physician thought that the arrow indicating the flow direction was upside down, however it was confirmed to be pointing in the right direction.There was difficulty in draining the liquid.When placing the system and connecting the valve, it was confirmed that there was no cerebrospinal fluid drainage after several attempts and even changing the direction of the reservoir.It was thought the slow drainage claim could be due to excessive ventricle drainage prior to connecting the valve.The valve was replaced and the procedure was concluded successfully.
Additional Manufacturer Narrative
The returned valve was patent.The valve met the requirements for reflux and leak testing.The valve did not meet the requirements for pressure-flow and preimplantation testing.The valve overdrained during testing.Therefore, the nature of the complaint could not be replicated by laboratory personnel.Particulate debris was observed on the interior and exterior of the valve.The instructions for use cautions, ¿care must be taken to ensure that particulate contaminants are not introduced into shunt components during preimplantation testing or handling.Introduction of contaminants could result in improper performance (over- or underdrainage) of the shunt system.Particulate matter that enters the shunt system may also hold pressure/flow controlling mechanisms open, resulting in overdrainage.¿ all valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CSF-FLOW CONTROL SHUNT KIT, ULTRA SMALL, 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: 8137856
• Report Number: 2021898-2018-00549
• Device Sequence Number: 194978
• Product Code: JXG
• UDI-Device Identifier: 00643169467149
• UDI-Public: 00643169467149
• Combination Product (Y/N): N
• Initial Reporter Country: PA
• PMA/510(K) Number: K873247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2019

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: 10/31/2022
• Device Model Number: 22011 M
• Device Catalogue Number: 22011 M
• Device Lot Number: E40654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1