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

Model Number AUTOGEN X4 CRTD

Device Problems Break (1069); High impedance (1291); High Capture Threshold (3266)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Monitonng showed an increase in impedance associated with an increase in the stimulation threshold in relation with a breakage of the conductor.Summons the patient for a change of leads and can.Device was extracted.(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: 17537586
• MDR Text Key: 321332137
• Report Number: MW5144459
• 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: AUTOGEN X4 CRTD
• Patient Sequence Number: 1