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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 Insufficient Information (3190)
Patient Problem Neurological Deficit/Dysfunction (1982)
Event Date 06/24/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that strata ii valve was implanted 11 months ago. The device was set initially at 2. 5 and gradually physician decreased the value set at 0. 5. There was a neurological worsening of the patient, so the physician replaced the strata ii valve with a new csf valve.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported that the physician changed the settings every 2 months from 2. 5 to 0. 5 during the scheduled follow-up due to a progressive worsening of the neurological conditions. It was stated during the explantation, the physician controlled the valve drainage. They observed there was no flux with the valve set at 0. 5. They performed the pumping on the reservoir, and the valve expelled the fluid. The patient was currently doing well.
 
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Brand NameSTRATA II VALVE, REGULAR
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
katcha taylor
9775 toledo way
irvine,ca, MN 92618
7635263305
MDR Report Key8776404
MDR Text Key150573542
Report Number2021898-2019-00271
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeIT
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 09/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2020
Device Model Number42866
Device Catalogue Number42866
Device Lot NumberE37521
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2017
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: 07/10/2019 Patient Sequence Number: 1
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