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

Model Number G124

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Inaccurate Synchronization (1609)

Patient Problem Atrial Fibrillation (1729)

Event Date 02/09/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded pacemaker mediated tachycardia (pmt) events following the extension post-ventricular atrial refractory period (pvarp).The atrial fibrillation (af) was induced following the pattern, potentially due to atrial pacing within the atrial vulnerable period.Additionally, far-field r-wave oversensing was observed.Review of the current blanking interval is required to mitigate inappropriate mode switches.Data was reviewed and the pmt events did show appropriate termination.Boston scientific technical services provided recommendations to prevent pacing induced af following a pmt.The healthcare professional should consider in-clinic testing for retrograde conduction, review the patient histograms and activity level trends, and consider the benefit of sensor-driven pacing.Review the current sensor settings.If clinically appropriate, consider reducing the sensor settings to pace slower if a similar situation reoccurs.Consider reviewing a blank after rv pace value to help prevent far-field r-wave oversensing.Review the current atr criteria settings and if clinically appropriate consider extending the criteria.Consider programming on atrial flutter response (afr) which provides immediate dissociation of the atrium and ventricle for atrial rates faster than the programmed afr trigger rate.No adverse patient effects were reported.This device remains in-service.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Please refer to b5 describe event or problem for more information regarding the specific circumstances of this event.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded pacemaker mediated tachycardia (pmt) events following the extension post-ventricular atrial refractory period (pvarp).The atrial fibrillation (af) was induced following the pattern, potentially due to atrial pacing within the atrial vulnerable period.Additionally, far-field r-wave oversensing was observed.Review of the current blanking interval is required to mitigate inappropriate mode switches.Data was reviewed and the pmt events did show appropriate termination.Boston scientific technical services provided recommendations to prevent pacing induced af following a pmt.The healthcare professional should consider in-clinic testing for retrograde conduction, review the patient histograms and activity level trends, and consider the benefit of sensor-driven pacing.Review the current sensor settings.If clinically appropriate, consider reducing the sensor settings to pace slower if a similar situation reoccurs.Consider reviewing a blank after rv pace value to help prevent far-field r-wave oversensing.Review the current atr criteria settings and if clinically appropriate consider extending the criteria.Consider programming on atrial flutter response (afr) which provides immediate dissociation of the atrium and ventricle for atrial rates faster than the programmed afr trigger rate.No adverse patient effects were reported.This device 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: 16769317
• MDR Text Key: 313581055
• Report Number: 2124215-2023-18595
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589102
• UDI-Public: 00802526589102
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/13/2019
• Device Model Number: G124
• Device Catalogue Number: G124
• Device Lot Number: 487447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other