MAUDE Adverse Event Report: BOSTON SCIENTIFIC 1-2. LNTELLAMAP ORION, LNTELLANAV MIFI OPEN IRRIGATED; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Visual Impairment (2138)

Event Date 03/31/2021

Event Type  Injury  

Event Description

The report comes from dr (b)(6) at (b)(6) hospital concerning boston scientific intellamap orion and boston scientific intellanav mifi open irrigated manufactured by: boston scientific.Please see event description below for more details: following an ablation procedure on (b)(6) 2021, the patient experienced a stroke on (b)(6) 2021.Blurring in the left eye occurred and no intervention was noted.The cause of the stroke is unknown to the physician.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: 1-2. LNTELLAMAP ORION, LNTELLANAV MIFI OPEN IRRIGATED
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17529104
• MDR Text Key: 321139363
• Report Number: MW5136033
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2021

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Treatment: OAD