MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM CRT-D; IMPLANTABLE DEFIBRILLATOR

Model Number G125

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)

Patient Problem Asystole (4442)

Event Date 01/18/2021

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited noise, oversensing and pacing inhibition of over two seconds on the right ventricular channel.It was determined that this was due to electromagnetic interference (emi).Additionally anti-tachycardia pacing (atp) was inappropriately delivered.It was discussed to contact the patient in order to address the source of the emi.No changes were performed on the device.This device remains in service.No further adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited noise, oversensing and pacing inhibition of over two seconds on the right ventricular channel.It was determined that this was due to electromagnetic interference (emi).Additionally anti-tachycardia pacing (atp) was inappropriately delivered.It was discussed to contact the patient in order to address the source of the emi.No changes were performed on the device.This device remains in service.No further adverse patient effects were reported.Additional information was received detailing that the issues with the device continue to appear and myopotential oversensing was the most likely root cause and discarded the idea of emi.Further evaluation of the patient was discussed.This device remains in service.No further adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited noise, oversensing and pacing inhibition of over two seconds on the right ventricular channel.It was determined that this was due to electromagnetic interference (emi).Additionally anti-tachycardia pacing (atp) was inappropriately delivered.It was discussed to contact the patient in order to address the source of the emi.No changes were performed on the device.This device remains in service.No further adverse patient effects were reported.Additional information was received detailing that the issues with the device continue to appear and myopotential oversensing was the most likely root cause and discarded the idea of emi.Further evaluation of the patient was discussed.This device remains in service.No further adverse patient effects were reported.

• Brand Name: MOMENTUM CRT-D
• Type of Device: IMPLANTABLE DEFIBRILLATOR
• 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: 16559607
• MDR Text Key: 311512885
• Report Number: 2124215-2023-12634
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589126
• UDI-Public: 00802526589126
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 05/03/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/19/2020
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 129740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 05/03/2023; 05/03/2023
• Supplement Dates FDA Received: 05/03/2023; 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Male