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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY STRATA NSC VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 42365
Device Problem Mechanics Altered (2984)
Patient Problems Neurological Deficit/Dysfunction (1982); Malaise (2359)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that last january, the patient went for a valve revision where apparently a doctor without enough experience tried to verify the valve with another manufacturer's calibration tool. The following day, the patient returned feeling very ill and dis-compensated. After they were hospitalized, the doctor called the manufacturer, and they provided the correct calibration tool. After being re calibrated with the calibration tool, the settings have remained constant. The doctor has claimed that the calibration has been okay since. However, the patient, without any improvement, has claimed that it was caused by the frequent valve dis calibration. It was noted that the doctors are not considering to change the valve; however, the patient insisted that their condition was caused because of the valve. The patient's status at the time of the report was alive-with injury. The patient is hospitalized with neurological deficit. The patient's relatives claim that the patient's condition was related to the frequent hydrocephalus valve changing settings due to magnetism.
 
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Brand NameSTRATA NSC 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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key10075222
MDR Text Key191588255
Report Number2021898-2020-00146
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K033850
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 05/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number42365
Device Catalogue Number42365
Device Lot NumberUNKNOWN
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 Received05/16/2020
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 Initial

Patient Treatment Data
Date Received: 05/20/2020 Patient Sequence Number: 1
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