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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DELTA VALVE, NEONATAL, PERFORMANCE LEVEL 1.5; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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MEDTRONIC NEUROSURGERY DELTA VALVE, NEONATAL, PERFORMANCE LEVEL 1.5; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 27219-5
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 03/20/2018
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 the patient experienced an accumulation of cerebrospinal fluid (csf) and head enlargement.There was no csf drainage with the device.The device was replaced with a new one and the patient¿s status was listed as no injury.
 
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Brand Name
DELTA VALVE, NEONATAL, PERFORMANCE LEVEL 1.5
Common Device Name
SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
MDR Report Key7382201
Report Number2021898-2018-00169
Device Sequence Number1426622
Product Code JXG
UDI-Device Identifier00643169507395
UDI-Public00643169507395
Combination Product (Y/N)N
Initial Reporter CountryTS
PMA/510(K) Number
K902783
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 03/29/2018
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 Date07/31/2021
Device Model Number27219-5
Device Catalogue Number27219-5
Device Lot NumberE16669
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/21/2018
Initial Report FDA Received Date03/29/2018
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 Weight5
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