• 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 Infusion or Flow Problem (2964)
Patient Problems Fatigue (1849); Headache (1880); Therapeutic Effects, Unexpected (2099); Vomiting (2144)
Event Date 03/26/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that in 2007, the patient was implanted with an adjustable pressure shunt due to hydrocephalus. On (b)(6) 2020, the patient had symptoms of vomiting, drowsiness, and headache. The next day, the patient went to the local hospital for a ct examination, and an enlarged ventricle was found. On (b)(6) 2020, the patient was transferred to another hospital for treatment. The doctor indicated that a mri examination was needed. At present, the patient was hospitalized and still had symptoms of drowsiness and headache. It was noted that the manufacturer representative had contacted the patient's family member, and their request was to help confirm the valve pressure before and after the mri examination. The distributor would operate it the morning of (b)(6) 2020.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported that the clinical team suspected it might be meningitis. The patient was being observed closely, and they were going to be re-examined after 4 days.
 
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
5290 california ave
irvine CA 92617
Manufacturer (Section G)
MEDTRONIC NEUROSURGERY
5290 california ave
irvine CA 92617
Manufacturer Contact
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9912352
MDR Text Key189669791
Report Number2021898-2020-00113
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 consumer,foreign
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? Yes
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2020
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: 04/01/2020 Patient Sequence Number: 1
-
-