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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY STRATA II VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 42866
Device Problem Complete Blockage (1094)
Patient Problem Cognitive Changes (2551)
Event Date 01/18/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient was admitted to the hospital due to normal pressure hydrocephalus. On (b)(6) 2020, they underwent ventricular-abdominal shunt surgery under general anesthesia. During the operation, the ventricular-abdominal shunt was used for drainage, and the patient's consciousness improved after the operation. On (b)(6) 2021, it was discovered that the patient's consciousness disorder was deeper than before. On (b)(6) 2021, the ventricular-abdominal shunt was replaced under general anesthesia. During the operation, the valve was found to be yellow and blocked. It was noted that it was considered the increase in cerebrospinal fluid protein or the presence of red blood cells to be the cause of the blockage. After the replacement, the patient's state of consciousness had improved.
 
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Brand NameSTRATA II VALVE, REGULAR
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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key11251633
MDR Text Key229371030
Report Number2021898-2021-00032
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K042465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number42866
Device Catalogue Number42866
Device Lot NumberE66951
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 Received02/11/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/12/2019
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: 01/29/2021 Patient Sequence Number: 1
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