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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DELTA SM EXTRACTED, PERFORMANCE LEVEL 1.5 SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY DELTA SM EXTRACTED, PERFORMANCE LEVEL 1.5 SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 27554-5
Device Problem Device Appears to Trigger Rejection (1524)
Patient Problems Hypersensitivity/Allergic reaction (1907); Irritation (1941)
Event Date 07/24/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the patient had a reaction to their implant. It was stated the patient had been experiencing irritation with their tubing/valve. They were tested for allergies, and xylene was found as an allergen for them.
 
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Brand NameDELTA SM EXTRACTED, PERFORMANCE LEVEL 1.5
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
Manufacturer (Section G)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
Manufacturer Contact
katcha taylor
9775 toledo way
irvine, CA 92618
7635263305
MDR Report Key9508146
MDR Text Key190554009
Report Number2021898-2019-00459
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K902783
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 12/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Model Number27554-5
Device Catalogue Number27554-5
Device Lot NumberE22644
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 Received12/03/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/15/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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