MAUDE Adverse Event Report: BOSTON SCIENTIFIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 018S

Device Problems Over-Sensing (1438); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 05/24/2022

Event Type  malfunction  

Event Description

Svc lead impedance warning on (b)(6) 2022.Possible farfield r wave oversensing on atrial channel causing at/af classification.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17489632
• MDR Text Key: 320706406
• Report Number: MW5122163
• Device Sequence Number: 1
• Product Code: LWS
• 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: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 018S
• Patient Sequence Number: 1