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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY CSF-FLOW CONTROL VALVE, BURR HOLE, 16MM, MEDIUM PRESSURE SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 42544
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that prior to the procedure, the physician found there was a ¿pressure problem. ¿ the valve was to be replaced and there was no injury to the patient.
 
Manufacturer Narrative
The returned valve was patent and met the requirements for reflux and leak testing. However, the valve did not meet the requirements for pressure-flow and preimplantation testing. There was proteinaceous debris on the interior of the valve. The instructions for use cautions, ¿care must be taken to ensure that p articulate contaminants are not introduced into shunt components during preimplantation testing or handling. Introduction of contaminants could result in improper performance (overdrainage or underdrainage) of the shunt system. Particulate matter, which 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.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported that the physician tested the shunt pressure before implantation, and they couldn't get a normal pressure.
 
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Brand NameCSF-FLOW CONTROL VALVE, BURR HOLE, 16MM, MEDIUM PRESSURE
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
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8200292
MDR Text Key131533500
Report Number2021898-2018-00588
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 03/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number42544
Device Catalogue Number42544
Device Lot NumberE42551
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2018
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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