MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA NSC BURR HOLE VALVE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	42335
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	10/20/2018
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 the drainage valve had poor elasticity.The valve was never implanted and there was no injury to the patient.
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for valve flux, reflux, leak, preimplantation and pressure-flow testing.Therefore, the nature of the complaint could not be replicated by laboratory personnel.There was proteinaceous debris noted within the exterior of the valve.The outlet of the valve was discolored.It is unknown how or when this discoloration occurred.All valves are 100% tested 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 the valve did not function well and there was no flow though the valve.It was unknown was caused the issue.

• Brand Name: STRATA NSC BURR HOLE VALVE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8170707
• Report Number: 2021898-2018-00566
• Device Sequence Number: 1747966
• Product Code: JXG
• UDI-Device Identifier: 00643169975781
• UDI-Public: 00643169975781
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K082127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2019

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: 12/31/2022
• Device Model Number: 42335
• Device Catalogue Number: 42335
• Device Lot Number: E41986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2018
• Supplement Date Received by Manufacturer: 12/19/2018; 01/18/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 01/12/2019; 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1