MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF VENTRICULAR PORT, 16 MM, SIDE INLET; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR

Model Number	44010
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	08/01/2019
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 the patient underwent intracranial pressure implantation surgery.After implantation of the device, the reservoir showed no fluid inflow, and the ventricle was circulated smoothly.After replacing the reservoir, it was normal.It was noted that this resulted in a 10 minute procedure delay.The patient's status at the time of the report was alive - no injury.
Additional Manufacturer Narrative
The returned reservoir met the requirements for leak testing.The reservoir was returned with a catheter that was 3.5 inches in length.Water was able to flow into the reservoir.Therefore, the nature of the complaint could not be replicated by laboratory personnel.Damage to the reservoir was observed on the dome.It is unknown how or when this damage occurred.The instructions for use cautions, ¿improper use of instruments in the handling or implantation of port products may result in the cutting, slitting or crushing of components.¿ proteinaceous debris was observed on the catheter returned with the reservoir.The instructions for use cautions, ¿obstruction may occur in any of the components of the ventricular port system.The system may become occluded internally due to tissue fragment, blood clots, tumor cell aggregates, bacterial colonization, pseudocyst, or other debris.All valves are 100% inspected at the time of manufacturing.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CSF VENTRICULAR PORT, 16 MM, SIDE INLET
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8861540
• Report Number: 2021898-2019-00304
• Device Sequence Number: 13578777
• Product Code: LKG
• UDI-Device Identifier: 00643169497108
• UDI-Public: 00643169497108
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K874468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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: 11/30/2023
• Device Model Number: 44010
• Device Catalogue Number: 44010
• Device Lot Number: E57853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1