• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC NEUROSURGERY UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-S
Device Problem Insufficient Information (3190)
Patient Problems Headache (1880); Seroma (2069)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Axel sandvig, kai arnell, jan malm, anders eklund, lars-owe d. Koskinen. Analysis of codman microcerebrospinal fluid shunt. Wiley brain and behavior (2018). Doi: 10. 1002/brb3. 1002 abstract introduction: ventriculo-peritoneal cerebrospinal fluid (csf) shunt is the most common method of treating pediatric hydrocephalus. The codman micro adjustable valve (cmav) is a csf shunt constructed for children. The objective of the study was (a) to analyze complications after insertion of a cmav shunt in hydrocephalic children, (b) to analyze complications after replacing a cmav by an adult-type codman hakim adjustable valve shunt (chav), and to (c) analyze the in vitro characteristics of the cmav shunt and correlate the findings with the clinical performance of the shunt. Methods: a retrospective study analyzed a cohort of hydrocephalic children who had received a cmav shunt and later replaced by a chav shunt. We report on the complications that resulted from replacing the cmav with the chav. We tested six cmav shunts with or without an antisiphon device (asd) in which opening pressure, resistance, sensitivity to abdominal pressure, asd position dependency, and function were determined. The test results were correlated with the clinical performance of the shunt in the retrospective study. Results: thirty-seven children (19 boys, 18 girls) were identified. Within the first month after shunt placement, a total of 10 patients (27%) developed complications including infections, hygromas, and shunt dysfunction. Shunt survival varied from 1 week to 145 months. Over the 10-year follow-up period, 13 children had their shunts replaced, six of them with a chav without any further complications. A bench test of the cmav was done to test whether the opening pressure was in agreement with the manufacturer¿s specifications. Our results were generally in agreement with specifications stated by the manufacturer. Conclusion: replacing a cmav with a chav was well tolerated by the patients. Bench test results were generally in agreement with manufacturers specifications. Replacing a cmav with a chav in pediatric hydrocephalus patients can be accomplished safely. Reported event. During the follow-up period, of 145 months, a total of 13 patients (35%) of 37 received a new shunt with a median 5 months to replacement (range between 1 and 113 months). The revision was due to proximal obstruction (n
=
6), distal obstruction (n
=
2), and a dysfunctional y-connection (n
=
1). Shunt replacement was due to infection (n
=
4; 31%), dysfunction of the valve (n
=
3; 23%), proximal obstruction (n
=
2; 15. 5%), and distal obstruction (n
=
2; 15. 5%). In five of these children, the shunt was exchanged to a chav, in four cases to a new cmav. One of those cmav shunts was later replaced with a chav. The other four patients had strata (n
=
1), standard hakim (n
=
1), or ventricular abdominal catheter inserted (n
=
2). Of the six children changing from cmav to chav, two experienced a persistent headache (had headache prior to change) that did not respond to any subsequent changes in the opening pressure. However, it is difficult to conclude that the headache was related to the type of shunt because they had headache before revision and of the small number of patients affected. In addition, the difference in resistance was insignificant when the cmav was compared with the chav. Furthermore, we found no shunt dysfunction that could explain the headaches. Of the other patients, one developed a hygroma postoperatively, which was successfully treated with adjustment of the valve. To note, only one of the manufacturer's device was used when the patients were changed from the cmav to the chav; however, it is unclear which of the patients experienced the reported events with the manufacturer's device if any.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN STRATA VALVE/SHUNT
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 Key8183368
MDR Text Key131505777
Report Number2021898-2018-00573
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 12/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN-S
Device Catalogue NumberUNKNOWN-S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-