• 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
Age or date of birth: 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. Sex: 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
Hideki kanemoto, hiroaki kazui, takashi suehiro, haruhiko kishima, yukiko suzuki, shunsuke sato, shingo azuma, takuya matsumoto, kenji yoshiyama, eku shimosegawa, toshihisa tanaka, manabu ikeda. "apathy and right caudate perfusion in idiopathic normal pressure hydrocephalus: a case-control study. " international journal of geriatric psychiatry 2018. Doi: 10. 1002/gps. 5038. Objectives: apathy is prevalent in patients with idiopathic normal pressure hydrocephalus (inph), a treatable disorder resulting from ventricular enlargement. We assessed the relationship between apathy and regional cerebral blood flow (rcbf) in patients with inph. Methods: before lumbo-peritoneal shunt surgery (lps), 56 inph patients were evaluated on apathy and dysphoria subscales of the neuropsychiatric inventory (npi), and were divided into two groups according to npi apathy score: 15 without apathy (inph-apa) and 41 with apathy (inph+apa). Among inph+apa, 29 patients were evaluated for apathy and dysphoria 3 months after lps, and were divided into two groups on the basis of the change in npi apathy score: 13 with improvement (inph+impapa) and 16 without improvement in apathy (inph-impapa). Nisopropyl- p-iodoamphetamine single photon emission computed tomography using the autoradiography method was performed before and after lps, and rcbf was calculated in 22 regions of interest in the frontal cortex, basal ganglia, and limbic system. Results: in inph+apa, rcbf in the right caudate nuclei before lps was significantly lower than that in inph-apa (p
=
0. 004; two-sample t test). Between inph-impapa and inph+impapa, a significant group-by-shunt interaction was observed for rcbf in only the right caudate nuclei (f1, 28
=
11. 75, p
=
0. 002; two-way repeated-measures analysis of variance), with increased rcbf in inph+impapa but not in inph-impapa. The significant group-by-shunt interaction persisted if change in npi dysphoria scores was used as a covariate (f1, 27
=
8. 33, p
=
0. 008). Conclusions: our findings suggest that right caudate dysfunction might cause apathy in inph patients. Reported events. 1 patient experienced a subdural hematoma within 3 months following lps.
 
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 Key8487324
MDR Text Key141055895
Report Number2021898-2019-00140
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
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 04/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2019
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 Received04/02/2019
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: 04/05/2019 Patient Sequence Number: 1
-
-