MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATAMR ASSEMBLY, SMALL; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	46955
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	03/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was unavailable for return as it remains implanted.Therefore an evaluation of the device performance was not possible.A review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.
Event or Problem Description
It was reported to medtronic neurosurgery that at first, the physician thought there was something wrong with the pressure adjustment.According to the report, the angle of the reported valve was different from the angle of another valve.When the doctor checked the angle, they suspected a malfunction of the setting.Reportedly, the manufacturer representative provided information for setting the pressure and the doctor was able to confirm the setting.The pressure setting was able to be adjusted and the device remained implanted.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATAMR ASSEMBLY, SMALL
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6461805
• Report Number: 2021898-2017-00148
• Device Sequence Number: 13601124
• Product Code: JXG
• UDI-Device Identifier: 00643169593442
• UDI-Public: 00643169593442
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2017

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: 05/31/2019
• Device Catalogue Number: 46955
• Device Lot Number: E12752
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2017
• Supplement Date Received by Manufacturer: 03/06/2017
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1