MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DELTA VALVE, REGULAR, PERFORMANCE LEVEL 2.0; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	42824
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Codes	Headache (1880); Therapeutic Response, Decreased (2271)
Date of Event	10/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned valve was patent.The valve met the requirements for siphon, reflux, and leak testing.However it did not meet the requirements for pressure flow and preimplantation testing.Proteinaceous debris was observed in the interior and on the 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.¿ all valves are 100% tested at the time of manufacture.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 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 the patient had persistent low-pressure headache symptoms consistent with overdrainage.It was stated the valve was tested on the back table after explant, and it slowed to 10-11cm pressure and continued to slowly drain.The proximal and distal catheters were working well.Following the explant, the patient was doing good.

• Brand Name: DELTA VALVE, REGULAR, PERFORMANCE LEVEL 2.0
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7109190
• Report Number: 2021898-2017-00652
• Device Sequence Number: 16471633
• Product Code: JXG
• UDI-Device Identifier: 00643169467156
• UDI-Public: 00643169467156
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K902783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 42824
• Device Catalogue Number: 42824
• Device Lot Number: E04341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention