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

Model Number	25014-5
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	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that there was no cerebrospinal fluid present in the shunt, and it did not drain at all from the start.The shunt was never implanted and replaced by another manufacturer's product.The patient's status at the time of the report was alive-no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported there were no external factors identified that may have led to the issue.

• Brand Name: DELTA UNITIZED SHUNT, SMALL
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7931274
• Report Number: 2021898-2018-00480
• Device Sequence Number: 16622849
• Product Code: JXG
• UDI-Device Identifier: 00613994965837
• UDI-Public: 00613994965837
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K902783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 25014-5
• Device Catalogue Number: 25014-5
• Device Lot Number: D62250
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 4 MO