• 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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Hemorrhage, Subdural (1894)
Event Type  Injury  
Manufacturer Narrative
Please note that this age is the average age of the patients reported in the article, as the actual age of patients involved was not provided. Please note that this is the gender of the majority of patients reported in the article as the actual genders of patients involved was not provided. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Chrisovalantis tsimiklis, annika mascarenhas, minh-son to, christine fairley bishop, felicity jenkinson, gemma hunt, natalie knight, marguerite harding, santosh poonnoose. The benefit of delayed reassessment post high-volume csf removal in the diagnosis of shunt-r esponsive idiopathic normal-pressure hydrocephalus. Journal of clinical neuroscience. Doi: 10. 1016/j. Jocn. 2019. 11. 011. A b s t r a c t the principle aim of the study was to demonstrate the value of performing delayed reassessment in the diagnosis of idiopathic normal -pressure hydrocephalus (inph) and selection of suitable candidates for ventriculoperitoneal shunting (vps). Thirty-one consecutive patients underwent the nph protocol at the flinders medical centre between march 2017 and november 2018. The protocol involved mobility and cognitive testing with reassessment post high-volume cerebrospinal fluid (csf) removal at 24 h and 48 h. The assessment of quality of life 6d (aqol-6d) questionnaire and international consultation on incontinence questionnaire ¿ urinary incontinence short form (iciq-ui sf) were completed and repeated again at 6 weeks and 6 months post shunting. Results were analysed to determine the significance of delayed reassessment. Twenty patients (64. 5%) underwent insertion of a vps on the basis of objective improvements and specific criteria. Of these, 6 patients (30%) were shunted based on delayed reassessment at 48 h post csf removal. Continued improvements were seen for all mobility and cognitive tests from baseline to 48 h post csf removal. At 6 weeks and 6 months post shunting, there was an overall mean improvement in aqol-6d and iciq-ui sf for the cohort and the improvement was also observed in the subgroup of patients who met shunt criteria at 48 h post csf removal. In the diagnosis of shunt-responsive idiopathic normal-pressure hydrocephalus, delayed reassessment post csf removal improves sensitivity and is therefore important. Reported event. - 1 patient (5%) developed an asymptomatic small subdural haematoma on routine delayed imaging. Again, their shunt valve was increased by a factor of 1 setting with resultant resolution of the subdural haematoma. This patient had a significant improvement based on the aqol-6d questionnaire but not the iciq-ui sf questionnaire at 6 weeks. Of the 20 patients shunted in this literature article, it was identified that the manufacturer's device was used; however, it is unclear whether the shunt malfunctions and revisions were involved with the manufacturer's device.
 
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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9612653
MDR Text Key176296510
Report Number2021898-2020-00025
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeAS
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 01/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received01/10/2020
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: 01/21/2020 Patient Sequence Number: 1
-
-