• 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 Appropriate Term/Code Not Available (3191)
Patient Problems Fatigue (1849); Dizziness (2194); Coma (2417); Ambulation Difficulties (2544)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
Event and implant dates are approximations. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the patient was implanted in 2011 due to hydrocephalus and the patient¿s condition had been good. In 2018, the patient began to appear drowsy and experience dizziness and they fell into a deep coma. The patient was sent to the hospital and the physicians believed that there was no obvious change in the ventricle. The valve was adjusted to 1. 5 and the patient woke up afterwards. It was stated the physician suspected the product was blocked. At present, the patient was still hospitalized and unable to walk, but was stable and conscious.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported the device was to remain implanted and the patient was in good condition at the time of this report.
 
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 Key8187642
MDR Text Key131124166
Report Number2021898-2018-00577
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2018
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 Received12/26/2018
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

Patient Treatment Data
Date Received: 12/20/2018 Patient Sequence Number: 1
-
-