MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G124

Device Problems High impedance (1291); Over-Sensing (1438)

Patient Problem Chest Pain (1776)

Event Date 01/01/2020

Event Type  malfunction  

Event Description

It was reported that this implantable cardiac resynchronization therapy defibrillator (crt-d) and other manufacturer leads had observations of the respiratory rate trend (rrt) sensor oversensing intermittent high out of range pacing impedances greater than 2000 ohms causing inappropriate atrial tachy response episodes.The patient had presented to the emergency room earlier this year with chest pain that could have been related to the noise and oversensing issue.Technical services recommended consider programming rrt feature off to help mitigate the issue.The system remains in-service.

• Brand Name: MOMENTUM CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 11104766
• MDR Text Key: 224788705
• Report Number: 2124215-2020-27136
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589102
• UDI-Public: 00802526589102
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/03/2020
• Device Model Number: G124
• Device Catalogue Number: G124
• Device Lot Number: 492992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR