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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II VALVE, SMALL; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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MEDTRONIC NEUROSURGERY STRATA II VALVE, SMALL; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 42856
Medical Device Problem Code Mechanics Altered (2984)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the issue with the valve was that it was at a different setting than it was originally set at.The doctor was concerned it was changing on its own/malfunctioning.The valve was taken out and replaced.They were not aware of any external factors affecting the issue.
 
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Brand Name
STRATA II VALVE, SMALL
Common Device Name
SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
MDR Report Key9564552
Report Number2021898-2020-00007
Device Sequence Number2901877
Product Code JXG
UDI-Device Identifier00643169975828
UDI-Public00643169975828
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K042465
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date12/31/2021
Device Model Number42856
Device Catalogue Number42856
Device Lot NumberE59412
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/30/2019
Initial Report FDA Received Date01/08/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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