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

Model Number	42856
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Hemorrhage, Subdural (1894)
Date of Event	11/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient developed a subdural hematoma (sdh) on an unknown date.No other information was provided.
Additional Manufacturer Narrative
Patient weight provided.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported the patient experienced a subdural on (b)(6) 2017.The patient underwent a left frontal craniotomy for evacuation of the acute subdural, though the date was not provided.The cause of the subdural was unknown.The subdural was not resolved, but had significantly decreased.
Additional Manufacturer Narrative
Outcome boxes checked.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: 7201686
• Report Number: 2021898-2018-00025
• Device Sequence Number: 917462
• Product Code: JXG
• UDI-Device Identifier: 00613994804631
• UDI-Public: 00613994804631
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2018

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: 03/31/2020
• Device Model Number: 42856
• Device Catalogue Number: 42856
• Device Lot Number: E30988
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2018
• Supplement Date Received by Manufacturer: 04/24/2018; 04/24/2018
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 04/24/2018; 04/24/2018
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 93