MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II SNAP SHUNT, SMALL; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	27816
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2017
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 while still in the sterile packaging, the surgeon was having difficulty adjusting the device to the appropriate settings.It was stated the setting ¿ended up between.¿ the device was replaced.
Additional Manufacturer Narrative
The returned valve was contained within the sealed product tray.All performance levels could be set with a single attempt, and the valve did not spontaneously change levels during the course of analysis.Therefore, the conditions of this complaint could not be verified by laboratory personnel.All valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported the device was not adjusted on a metal table.In addition, the adjustment tool was moved the appropriate distance away when reading the valve.The alignment of the adjustment tool and valve was maintained when in close proximity.

• Brand Name: STRATA II SNAP SHUNT, SMALL
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7088910
• Report Number: 2021898-2017-00634
• Device Sequence Number: 16413949
• Product Code: JXG
• UDI-Device Identifier: 00643169010529
• UDI-Public: 00643169010529
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2018

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: 02/29/2020
• Device Model Number: 27816
• Device Catalogue Number: 27816
• Device Lot Number: E29298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1