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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 Problems Fatigue (1849); Incontinence (1928); Pain (1994); Blurred Vision (2137); Vomiting (2144)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the patient was getting worse for their shunt procedure in 2017. Their symptoms had been: vomiting, blurred vision, lack of energy, pain in areas from ear to their stomach, and they had been wearing diapers from bladder issues. Their last shunt adjustment was (b)(6) 2019 after an mri.
 
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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
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8729110
MDR Text Key149226878
Report Number2021898-2019-00247
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 06/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Model Number42866
Device Catalogue Number42866
Device Lot NumberE29359
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/29/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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