MAUDE Adverse Event Report: NEUROBLATE® SYSTEM

Model Number	20360
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); No Code Available (3191)
Date of Event	09/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following an ablation procedure, a patient experienced an intracerebral hemorrhage.The patient required medical intervention, a decompressive crainectomy with expansion duraplasty and intracranial pressure monitoring.The physician stated this event is related to neuroblate and possibly related to the surgical procedure.The event is considered ongoing.
Event or Problem Description
Additional information received from the physician stated that the patient was "doing well".There were no further patient complications reported in relation to this event.
Event or Problem Description
According to a laantern ae update on 11oct2021, the description was updated from just intracerebral hemorrhage (ich) to ich, word finding difficulty and right side weakness, and additional seriousness criterion of requiring intervention to prevent permanent impairment of a body structure or body function was indicated.
Additional Manufacturer Narrative
Additional information: b5.

• Brand Name: NEUROBLATE® SYSTEM
• Common Device Name: NEUROBLATE® SYSTEM
• MDR Report Key: 7992235
• Report Number: 3009970070-2018-00078
• Device Sequence Number: 13864316
• Product Code: GEX
• UDI-Device Identifier: 00816589020656
• UDI-Public: 00816589020656
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K173305
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 20360
• Device Catalogue Number: NB102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 12/11/2018; 10/11/2021
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 12/17/2018; 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 YR