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

Model Number G124

Device Problems Under-Sensing (1661); Delayed Charge Time (2586)

Patient Problem Syncope/Fainting (4411)

Event Date 08/07/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited undersensing on the right ventricular channel during an intrinsic ventricular tachycardia episode, in which the patient also experienced a syncope.The device was able to deliver appropriately one shock, ending the episode.However, it was noted that, due to this undersensing, the therapy could have been delivered slightly sooner (less than one second).Reprograming of the device was discussed.This device remains in service.No further adverse patient effects were reported.Additional information was received detailing that this device was explanted and replaced.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited undersensing on the right ventricular channel during an intrinsic ventricular tachycardia episode, in which the patient also experienced a syncope.The device was able to deliver appropriately one shock, ending the episode.However, it was noted that, due to this undersensing, the therapy could have been delivered slightly sooner (less than one second).Reprograming of the device was discussed.This device remains in service.No further adverse patient effects were reported.Additional information was received detailing that this device was explanted and replaced.This device was returned to boston scientific for analysis.

• 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: 17653280
• MDR Text Key: 322318273
• Report Number: 2124215-2023-46940
• Device Sequence Number: 1
• Product Code: NIK
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

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: 02/11/2022
• Device Model Number: G124
• Device Catalogue Number: G124
• Device Lot Number: 497843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2020
• 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: 71 YR
• Patient Sex: Male