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

Catalog Number	42335
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was unavailable for return.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 device was implanted in (b)(6).According to the report, the patient went to have the device checked and the setting had changed.Reportedly, the patient had not been near any magnetic field that would affect the change and only used a cordless phone.
Additional Manufacturer Narrative
Additional information received reported the patient had not been doing as well as expected.According to the report, when the device was checked in january 2017, the setting had changed from 2.5 to 1.5.Reportedly, as of (b)(6) 2017, the patient was doing fine.Event date is an approximation.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.

• 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: 6313271
• Report Number: 2021898-2017-00048
• Device Sequence Number: 18842360
• Product Code: JXG
• UDI-Device Identifier: 00613994380104
• UDI-Public: 00613994380104
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K082127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2017

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: 08/31/2016
• Device Catalogue Number: 42335
• Device Lot Number: D47346
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2017
• Supplement Date Received by Manufacturer: Not provided; 06/19/2017
• Initial Report FDA Received Date: 02/08/2017
• Supplement Report FDA Received Date: 06/28/2017; 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1