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

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.

• Brand Name: DELTA®
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona dr.; goleta CA 93117
• MDR Report Key: 8146011
• MDR Text Key: 129781654
• Report Number: 8146011
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 42812
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/13/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/10/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1