MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA NSC SNAP SHUNT ASSEMBLY, REGULAR; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	27740
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2018
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 shunt was defective and the valve would not adjust pre-operatively.There was no patient impact.
Additional Manufacturer Narrative
The returned valve was left in the packaging so lab personnel could try to duplicate the complaint.Laboratory personnel were able to adjust the performance level setting to 2.5, 2.0, 1.5 and 1.0, but not 0.5 through the packaging.It is unknown how or when this occurred.The valve was not tested for valve flux, patency, leak, reflux, pressure-flow and preimplantation testing as it was not related to the complaint.All valves are 100% tested at the time of manufacture.Prior to release, the valve is set to each setting in order to perform pressure flow testing.A review of the manufacturing records showed no anomalies.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA NSC SNAP SHUNT ASSEMBLY, REGULAR
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7943595
• Report Number: 2021898-2018-00488
• Device Sequence Number: 11141513
• Product Code: JXG
• UDI-Device Identifier: 00643169975569
• UDI-Public: 00643169975569
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K033850
• 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
• 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: 01/31/2023
• Device Model Number: 27740
• Device Catalogue Number: 27740
• Device Lot Number: E42605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 10/08/2018
• 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