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

Model Number	42822
Medical Device Problem Codes	Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the procedure, the shunt was did not work after the valve was placed and attached to the ventricular and peritoneal catheters.The clinician palpated the valve prior to implant and it was working properly during palpation.After implanting the valve, the clinician thought the valve was not working properly.It was reportedly only working when being pumped.Therefore, a different valve was opened to complete the procedure.The patient¿s status was noted as no injury.
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for siphon, reflux, pressure-flow, preimplantation and leak testing.Therefore the conditions of this complaint could not be verified by laboratory personnel.There was proteinaceous debris observed within the interior and exterior of the valve.Debris within the valve may hold pressure-flow controlling mechanisms open affecting the flow of fluid through the valve.The instructions for use that accompany the device caution that ¿shunt obstruction may occur in any of the components of the shunt system.The system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization, or other debris.¿ a review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of the manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that the valve was not draining cerebrospinal fluid during the procedure.The cause of the issue was not determined.Following the revision, the condition of the patient was fine.

• Brand Name: DELTA®
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6852313
• Report Number: 2021898-2017-00472
• Device Sequence Number: 684395
• Product Code: JXG
• UDI-Device Identifier: 00643169466869
• UDI-Public: 00643169466869
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K902783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2017

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: 09/30/2019
• Device Model Number: 42822
• Device Catalogue Number: 42822
• Device Lot Number: D68213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2017
• Supplement Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 10/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR