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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
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Death (1802)
Type of Reportable Event Death
Additional Manufacturer Narrative
Date of death was not reported.The initial reporter is an attorney.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
The attorney reported they were preparing to file a wrongful death suit after their client died from a malfunction of the valve.No further information was reported.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
STRATA II VALVE, REGULAR
Common Device Name
SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
MDR Report Key8298114
Report Number2021898-2019-00045
Device Sequence Number11298128
Product Code JXG
UDI-Device Identifier00613994804648
UDI-Public00613994804648
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K042465
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 03/21/2019
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 Date02/28/2019
Device Model Number42866
Device Catalogue Number42866
Device Lot NumberE10238
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/09/2019
Supplement Date Received by Manufacturer03/21/2019
Initial Report FDA Received Date02/01/2019
Supplement Report FDA Received Date03/21/2019
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 Death;
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