• 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 STRATA NSC LUMBOPERITONEAL SHUNT KIT 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 STRATA NSC LUMBOPERITONEAL SHUNT KIT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 44420
Device Problems Complete Blockage (1094); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 03/01/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Yan-hua su, chi-lu chiang, huai-che yang, yong-sin hu, yu-wei chen, yung-hung luo, ching-jen chen, hsiu-mei wu, chung-jung lin, and cheng-chia lee. Cerebrospinal fluid diversion and outcomes for lung cancer patients with leptomeningeal carcinomatosis. Acta neurochirurgica (2021). Doi: 10. 1007/s00701-021-04763-w. Abstract objective to investigate the outcomes of cerebrospinal fluid (csf) diversion in lung cancer patients with leptomeningeal carcinomatosis (lmc). Methods a retrospective review of consecutive lung cancer patients with lmc suffering from increased intracranial pressure (iicp) and hydrocephalus between february 2017 and february 2020. We evaluated the survival benefit of csf diversion surgery and assessed the outcomes of treatments administered post-lmc in terms of overall survival and shunt-related complications. Results the study cohort included 50 patients (median age: 59 years). Ventricular peritoneal (vp) shunts were placed in 33 patients, and lumbar peritoneal (lp) shunts were placed in 7 patients. Programmable shunts were placed in 36 patients. Shunt adjustment was performed in 19 patients. Kaplan-meier analysis revealed that shunt placement increased overall survival from 1. 95 months to 6. 21 months (p
=
0. 0012) and increased karnofsky performance scores (kps) from 60 to 70. Univariate analysis revealed no difference between vp or lp shunts in terms of survival. No differences in post-shunt systemic treatments (tyrosine kinase inhibitors (tkis) or systemic treatments) were observed in overall survival. Shunt-related complications were noted in 7 patients, including shunt obstruction (n
=
4), infection (n
=
1), and over-drainage (n
=
2). Conclusion csf diversion (vp or lp shunt) appears to be an effective and safe treatment for lung cancer patients with lmc and hydrocephalus. Programmable shunts should be considered for complex cases, which commonly require pressure adjustments as the disease progresses. Reported events. - infection was detected in 1 vp shunt patient (2. 5%), which necessitated multiple revision surgeries. - shunt obstruction was detected in 3 vp shunt patients and 1 lp shunt patient (10% overall). Two cases of obstruction were treated using revision surgery and two underwent hospice care.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTRATA NSC LUMBOPERITONEAL SHUNT KIT
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 Key11734177
MDR Text Key247601649
Report Number2021898-2021-00100
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K091312
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number44420
Device Catalogue Number44420
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 Received06/09/2021
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: 04/27/2021 Patient Sequence Number: 1
-
-