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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-FLOW CONTROL VALVE, BURR HOLE, MEDIUM 16MM SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY CSF-FLOW CONTROL VALVE, BURR HOLE, MEDIUM 16MM SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Catalog Number 42544
Device Problem Inaccurate Flow Rate (1249)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2016
Event Type  malfunction  
Manufacturer Narrative
The returned valve was patent. The valve met the requirements for reflux, and leak testing. However, it did not meet the requirements for pressure-flow and preimplantation testing. There was proteinaceous debris noted in the interior and exterior of the device. Debris within the valve may hold pressure-flow controlling mechanisms open affecting the flow of fluid through the valve. The instructions for use (ifu) that accompany the device caution that ¿shunt obstruction may occur in any of the components of the shunt system. The system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization, or other debris. ¿ also, the instructions for use describe the patency test procedure for csf burr hole valves as follows: depress the valve dome, place a finger over the opening at the end of the outlet connector and release the depressed dome. If fluid enters the reservoir, the inlet connector and flow control membrane valve are patent. Following that, remove finger from the outlet connector opening and depress dome. If fluid flows out of the outlet connector, the valve is patent. A review of the manufacturing records showed no anomalies. All valves are 100% tested at the time of manufacture. 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.
 
Event Description
It was reported to medtronic neurosurgery that during testing prior to implantation, the physician attempted to pump the valve inside saline solution, but noticed there was no fluid flow. According to the report, the valve was replaced with a new valve and the procedure was completed without any complication. There was no injury to the patient.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameCSF-FLOW CONTROL VALVE, BURR HOLE, MEDIUM 16MM
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
Manufacturer (Section G)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
Manufacturer Contact
bob shokoohi
125 cremona drive
goleta, CA 93117
8055718725
MDR Report Key6179623
MDR Text Key62532156
Report Number2021898-2016-00477
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
K831678
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Catalogue Number42544
Device Lot NumberD74367
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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