• 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 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 VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-V
Device Problems Complete Blockage (1094); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intracranial Hemorrhage (1891); Unspecified Infection (1930); Seroma (2069); Convulsion/Seizure (4406)
Event Date 03/23/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Xiangtong zhang, xiaofeng fang, aili gao2, dong guan, chunmei guo, sen wang, yongan chen, boxian zhao, kongbin yang, enxi hu, hongsheng liang, fulan hu. Safety analysis of simultaneous cranioplasty and ventriculoperitoneal shunt placement. Turkish neurosurger (2021). Doi: 10. 5137/1019-5149. Jtn. 30740-20. 2 abstract aim: to investigate the safety of combined cranioplasty (cp) and ventriculoperitoneal shunt (vps) placement. Furthermore, we investigated whether the sequence of these procedures affects the postoperative complication rates associated with staged cp and vps placement. Material and methods: we retrospectively investigated patients who developed communicating hydrocephalus after decompressive craniectomy and subsequently underwent vps placement and cp at the hospital at which this study was performed between (b)(6) 2009 and (b)(6) 2019. Patients were categorized into group 1 (simultaneous cp and vps placement) and group 2 (cp and vps placement performed separately). Group 2 was subcategorized into subgroup 2a (cp performed before vps placement) and subgroup 2b (vps placement performed before cp). The student¿s t and chi square tests were used to analyze intergroup differences. Results: this study included 86 patients; 22 in group 1 and 64 in group 2 (24 patients in subgroup 2a and 40 patients in subgroup 2b). No statistically significant difference was observed in the overall complication rates between groups 1 and 2 (36. 4% vs. 28. 1%, p
=
0. 591). However, the incidence of infections was significantly higher in group 1 than in group 2 (22. 7% vs. 4. 7%, p
=
0. 024). Subgroup analysis showed that the overall complication rate was significantly lower in subgroup 2a than in subgroup 2b (12. 5% vs. 37. 5%, p
=
0. 031). Conclusion: simultaneous cp and vps placement is associated with a high incidence of infections. Moreover, compared with initial cp, initial vps placement is associated with a significantly higher risk of overall complications in patients who undergo a staged procedure. Reported events: - postoperative complications occurred in 26 of 86 patients (30. 2%), including infection in 8 patients (5 in group 1, 3 in group 2), obstruction in 3 patients (group 2), seizure in 3 patients (1 in group 1, 2 in group 2), epidural hemorrhage in 3 patients (group 2), epidural hygroma in 8 patients (3 in group 1, 5 in group 2), and sinking skin flap syndrome (ssfs)/paradoxical herniation in 6 patients (group 2). See attached literature article.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN VALVE/SHUNT
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
5290 california ave
irvine CA 92617
Manufacturer (Section G)
MEDTRONIC NEUROSURGERY
5290 california ave
irvine CA 92617
Manufacturer Contact
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12001485
MDR Text Key256273747
Report Number2021898-2021-00129
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeCH
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 06/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN-V
Device Catalogue NumberUNKNOWN-V
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 Received05/31/2021
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

Patient Treatment Data
Date Received: 06/15/2021 Patient Sequence Number: 1
-
-