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

Model Number	27219-5
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2019
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 one end of the valve was found to be wobbly instead of rigid.It was noted that this was how the physician remembered the valve to be, rigid on each end so they could get it onto the catheter.
Additional Manufacturer Narrative
The returned valve was patent.The valve met the requirements for leak, siphon, reflux, pressure-flow and preimplantation testing.The inlet connector is not connected to the rest of the rigid internal components.Therefore, it is not an anomaly that it is flexible instead of rigid.All valves are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
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 was no injury to the patient.The patient's current status was fine.There were no environmental/external/patient factors that may have led or contributed to the issue.

• Brand Name: DELTA VALVE, NEONATAL
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8434920
• Report Number: 2021898-2019-00113
• Device Sequence Number: 19145923
• Product Code: JXG
• UDI-Device Identifier: 00643169507395
• UDI-Public: 00643169507395
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K902783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2019

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: 09/30/2023
• Device Model Number: 27219-5
• Device Catalogue Number: 27219-5
• Device Lot Number: E54491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 03/20/2019; 03/29/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 03/29/2019; 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Weight: 3