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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DELTA VALVE, REGULAR, PERFORMANCE LEVEL 2.0 SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY DELTA VALVE, REGULAR, PERFORMANCE LEVEL 2.0 SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 42824
Device Problem Inaccurate Flow Rate (1249)
Patient Problems Headache (1880); Therapeutic Response, Decreased (2271)
Event Date 10/21/2017
Event Type  Injury  
Manufacturer Narrative
The returned valve was patent. The valve met the requirements for siphon, reflux, and leak testing. However it did not meet the requirements for pressure flow and preimplantation testing. Proteinaceous debris was observed in the interior and on the exterior of the valve. Debris within the valve may hold pressure-flow controlling mechanisms open affecting the flow of fluid through the valve. The instructions for use 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. ¿ all valves are 100% tested at the time of manufacture. Medtronic, inc. (medtronic) is submitting this report to comply with 21 c. F. R. Part 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 that the patient had persistent low-pressure headache symptoms consistent with overdrainage. It was stated the valve was tested on the back table after explant, and it slowed to 10-11cm pressure and continued to slowly drain. The proximal and distal catheters were working well. Following the explant, the patient was doing good.
 
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Brand NameDELTA VALVE, REGULAR, PERFORMANCE LEVEL 2.0
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 Key7109190
MDR Text Key94545100
Report Number2021898-2017-00652
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K902783
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 12/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Model Number42824
Device Catalogue Number42824
Device Lot NumberE04341
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/12/2017 Patient Sequence Number: 1
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