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

Catalog Number	42856
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	03/08/2017
Type of Reportable Event	Serious Injury
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 patient's device was checked after an mri and had the setting of 2.5 on (b)(6) 2016, and on a follow up appointment on (b)(6) 2017, the setting was on 0.5.According to the report, the patient was not around any magnets nor used electronic devices.It was stated the patient was kept away from magnets.Reportedly, the patient¿s mother was worried with the device changing from the lowest setting to the highest setting, it could cause another bleed in the patient¿s brain.It was noted that the patient has had several mri's while having their device.The neurosurgeon adjusted it back to 2.5 and said they would see the patient in 6 months for a checkup, however, it was indicated the patient had a follow up appointment with the neurosurgeon to check the settings on (b)(6) 2017.It was mentioned that the patient had development issues so they didn't indicate symptoms to know when the valve had changed settings.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA II VALVE, SMALL
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6472171
• Report Number: 2021898-2017-00164
• Device Sequence Number: 332922
• Product Code: JXG
• UDI-Device Identifier: 00613994804631
• UDI-Public: 00613994804631
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042465
• 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
• Report Date (Section B): 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 42856
• Device Lot Number: E00327
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2017
• Supplement Date Received by Manufacturer: 03/08/2017
• Initial Report FDA Received Date: 04/07/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 YR
• Patient Weight: 11