MAUDE Adverse Event Report: MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number 4574

Device Problems Impedance Problem (2950); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) heard beep tones.Boston scientific technical services (ts) referred the patient to their health care professional (hcp).The device was interrogated and the beeping tones were resolved.However, it was noted that there was a one-off atrial lead impedance out of range (less than 200ohms).No adverse patient effects were reported.Currently evidence suggests that this product remains in-service.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17531698
• MDR Text Key: 321186927
• Report Number: MW5138611
• 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: 04/01/2020

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
• Device Model Number: 4574
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1