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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY CSF-FLOW CONTROL VALVE, BURR HOLE 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 12/17/2015
Event Type  malfunction  
Manufacturer Narrative
The product was unavailable for return. Therefore, an evaluation of the device performance was not possible. A review of the manufacturing records showed no anomalies. All valves are 100% tested at the time of manufacture. (b)(4).
 
Event Description
It was reported to medtronic neurosurgery that the device was found to not drain properly prior to use. According to the report, the doctor used a new device to complete the surgery. Reportedly, there was no injury to the patient.
 
Manufacturer Narrative
The returned valve was patent. It met the requirements for reflux, pressure-flow, preimplantation, and leak testing. Therefore the conditions of the complaint could not be duplicated by laboratory personnel. The instructions for use that accompany the device instruct that when performing the patency check: a. Place the inlet connector of the valve into sterile isotonic saline. B. Depress the valve dome. C. Place a finger over the opening at the end of the outlet connector. D. Release the depressed dome. If fluid enters the reservoir, the inlet connector and flow control membrane valve are patent. E. Remove finger from the outlet connector opening. F. Depress dome. If fluid flows out of the outlet connector, the valve is patent. Note: it may be necessary to depress the valve dome more than once to initiate flow, especially if the ventricular catheter has been attached prior to patency testing. A review of the manufacturing records showed no anomalies. All valves are 100% tested at the time of manufacture. (b)(4).
 
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
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
jeffrey henderson
125 cremona drive
goleta, CA 93117
8055718445
MDR Report Key5382846
MDR Text Key36555678
Report Number2021898-2016-00029
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeTW
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,Followup
Report Date 12/22/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2017
Device Catalogue Number42544
Device Lot NumberD37035
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/16/2013
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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