MAUDE Adverse Event Report: BOSTON SCIENTIFIC DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number G150

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 02/05/2021

Event Type  Injury  

Event Description

It was reported that the patient experienced extra cardiac stimulation and diaphragmatic pacing on (b)(6) 2021.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17533602
• MDR Text Key: 321050048
• Report Number: MW5140506
• Device Sequence Number: 1
• Product Code: NIK
• 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: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: G150
• Patient Sequence Number: 1