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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LLC STRATA II VALVE, REGULAR, WITH BIOGLIDE SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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COVIDIEN LLC STRATA II VALVE, REGULAR, WITH BIOGLIDE SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 92866
Device Problem Complete Blockage (1094)
Patient Problem Insufficient Information (4580)
Event Date 03/04/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that about 15 days after implantation, it was found that the shunt was not smooth, and the patient's intracranial pressure was high. It was judged that the valve was blocked, so on (b)(6) 2021, it was replaced. After the replacement, the patient recovered well and had been discharged from the hospital.
 
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Brand NameSTRATA II VALVE, REGULAR, WITH BIOGLIDE
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
COVIDIEN LLC
15 hampshire street
mansfield 02048
Manufacturer (Section G)
COVIDIEN LLC
15 hampshire street
mansfield 02048
Manufacturer Contact
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key11517318
MDR Text Key240728122
Report Number9612501-2021-00430
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number92866
Device Catalogue Number92866
Device Lot Number0219123854
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/24/2020
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: 03/18/2021 Patient Sequence Number: 1
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