MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D)

Model Number G138

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

Patient Problem Asystole (4442)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillators (crt-d) device exhibited noise and oversensing on the right ventricular (rv) channel.This oversensing of the noisy signals led to pacing inhibition.The healthcare professional was able to reproduce the noise with isometrics, however oversensing was not seen.There were concerns for possible asystole greater than 2 seconds.Boston scientific representative indicated that the patient was seen in clinic and were able to reproduce the noise with isometrics but there was no oversensing observed.Patient was using an electric tiller potentially at the time of the possible organized emi type noise.There was no change in impedance during the noise.This crt-d device remains in service.No patient adverse effects were reported.Additional information received indicated that the tiller was not the cause of the oversensing.The patient is going to have the rv lead revision in upcoming months.No adverse effects were reported.

Manufacturer Narrative

This report captures the explant of this device and impact on the patient.

Event Description

It was reported that this cardiac resynchronization therapy defibrillators (crt-d) device exhibited noise and oversensing on the right ventricular (rv) channel.This oversensing of the noisy signals led to pacing inhibition.The healthcare professional was able to reproduce the noise with isometrics, however oversensing was not seen.There were concerns for possible asystole greater than 2 seconds.Boston scientific representative indicated that the patient was seen in clinic and were able to reproduce the noise with isometrics but there was no oversensing observed.Patient was using an electric tiller potentially at the time of the possible organized emi type noise.There was no change in impedance during the noise.This crt-d device remains in service.No patient adverse effects were reported.Additional information received indicated that the tiller was not the cause of the oversensing.The patient is going to have the rv lead revision in upcoming months.No adverse effects were reported.Additional information received indicated that the device was explanted and successfully replaced.No additional patient adverse effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillators (crt-d) device exhibited noise and oversensing on the right ventricular (rv) channel.This oversensing of the noisy signals led to pacing inhibition.The healthcare professional was able to reproduce the noise with isometrics, however oversensing was not seen.There were concerns for possible asystole greater than 2 seconds.Boston scientific representative indicated that the patient was seen in clinic and were able to reproduce the noise with isometrics but there was no oversensing observed.Patient was using an electric tiller potentially at the time of the possible organized emi type noise.There was no change in impedance during the noise.This crt-d device remains in service.No patient adverse effects were reported.Additional information received indicated that the tiller was not the cause of the oversensing.The patient is going to have the rv lead revision in upcoming months.No adverse effects were reported.Additional information received indicated that the device was explanted and successfully replaced.No additional patient adverse effects were reported.

Manufacturer Narrative

The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.All setscrews moved freely in both directions.Dimensional analysis of the header was completed.A manual shock test was performed on the device.And the device passed the test at 42-ohms.All five seal plugs on the header were inspected under high power and a hole was found on the lv seal plug.A hole on the lv seal plug would not cause noise on the rv channel.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.This report captures the explant of this device and impact on the patient.

• Brand Name: MOMENTUM X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (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: 16831480
• MDR Text Key: 314170316
• Report Number: 2124215-2023-20560
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589188
• UDI-Public: 00802526589188
• 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: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2022
• Device Model Number: G138
• Device Catalogue Number: G138
• Device Lot Number: 385872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 06/05/2023; 01/11/2024
• Supplement Dates FDA Received: 06/14/2023; 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2020
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male