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

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

It was reported that electrogram (egm) review of the cardiac resynchronization therapy defibrillator (crt-d) system revealed oversensed right ventricular (rv) lead noise with greater than two seconds of pacing inhibition.Additionally, the patient's ejection fraction had normalized, and the physician may consider downgrading the implanted system.At this time, rv sensitivity was raised to 1.5mv, biventricular (biv) pacing was programmed on, and noise response was on as well.Boston scientific technical services (ts) reviewed programming considerations and possible concerns.Additional information received reported that this right ventricular (rv) lead was explanted and replaced.No additional adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Reference report: #mw5149064.

• Brand Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18301900
• MDR Text Key: 330430833
• Report Number: MW5149065
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1