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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DELTA SHUNT KIT, SMALL PERFORMANCE LEVEL 2.0; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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MEDTRONIC NEUROSURGERY DELTA SHUNT KIT, SMALL PERFORMANCE LEVEL 2.0; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 25131-2
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/11/2019
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 after 2 weeks of shunt installation, the valve was not working properly.It was stated that it stopped working with pressure 140-160, but only up to 170.The valve was explanted and replaced with another valve.The patient was implanted for triventricular hydrocephalus.
 
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Brand Name
DELTA SHUNT KIT, SMALL PERFORMANCE LEVEL 2.0
Common Device Name
SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
MDR Report Key9293247
Report Number2021898-2019-00401
Device Sequence Number16670168
Product Code JXG
UDI-Device Identifier00643169472778
UDI-Public00643169472778
Combination Product (Y/N)N
Initial Reporter CountryRS
PMA/510(K) Number
K902783
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/07/2019
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 Date01/31/2021
Device Model Number25131-2
Device Catalogue Number25131-2
Device Lot NumberE09997
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/06/2019
Initial Report FDA Received Date11/07/2019
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 Hospitalization; Required Intervention;
Patient Age3 MO
Patient Weight4
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