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

Catalog Number	42965
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Nausea (1970); Vomiting (2144)
Date of Event	05/10/2017
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 the patient presented for an office visit on (b)(6) 2017.According to the report, the patient experienced no improvement to their baseline condition since the last adjustment that went from a setting of 2.0 to 1.5.It was stated that the device was adjusted from 1.5 to 1.0 without difficulty.The patient then experienced a worsening of nausea and vomiting and went to the emergency room on (b)(6).Reportedly, the device was adjusted to 1.5, but difficulty was experienced when adjusting.The patient had an x-ray that showed the device being at 1.0.It was reported that the patient declined to have the device readjusted to 1.5 because their symptoms resolved the next day.The device was not explanted and the patient was at home.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATAMR VALVE, REGULAR
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6620903
• Report Number: 2021898-2017-00317
• Device Sequence Number: 10881517
• Product Code: JXG
• UDI-Device Identifier: 00643169692701
• UDI-Public: 00643169692701
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2017

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: 09/30/2017
• Device Catalogue Number: 42965
• Device Lot Number: E11655
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2017
• Supplement Date Received by Manufacturer: 05/12/2017
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2021898-022217-001-R
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 118