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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DELTA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY DELTA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 42812
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Information (3190)
Event Date 06/12/2018
Event Type  malfunction  
Event Description
Poor manufacturer labeling contributed to incorrect shunt selection. The manufacturer label does not specify if a shunt is programmable vs. Nonprogrammable. The lettering identifying the name of the device is very small and difficult to read. Additionally, the sterile packaging is not labeled.
 
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Brand NameDELTA®
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona dr.
goleta CA 93117
MDR Report Key8146011
MDR Text Key129781654
Report Number8146011
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model Number42812
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/13/2018
Event Location Hospital
Date Report to Manufacturer12/10/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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