MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G138

Device Problems Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Data Problem (3196)

Patient Problem Electric Shock (2554)

Event Date 11/25/2020

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) delivered atp and one 21j shock for atrial fibrillation (afib) with rapid ventricular response (rvr).This was reported to be an isolated episode.The shock successfully converted the patient.The health care professional (hcp) stated that the afib was a newly developed condition for the patient and the hcp consulted with technical services regarding troubleshooting and programming options.The patient is not dependent.Device optimization was recommended needed.Patient is being brought into the clinic for further evaluation.The device system remains in-service at this time.No adverse patient effects were reported.Additional information was received that the patient was admitted to the hospital after receiving inappropriate atp and shock therapy for atrial fibrillation with rapid ventricular response (rvr).Additionally, the shock therapy had terminated the fast ventricular rhythm and converted the patient atrial fibrillation.The patient reported feeling fine leading up to the inappropriate shock delivery.It was noted that upon review of the stored electrograms (egm) and data, that the data was not reflective of the current atrial fibrillation as the percentage of atrial fibrillation currently displayed zero percent which was found not to be true.Technical services (ts) was consulted for troubleshooting and programming options.Ts confirmed that at the time of the remote monitoring transmission for data review, the device data had not been completely transferred, therefore the atrial fibrillation data was not accurate until all of the device data was transferred.This was found to be normal device behavior.The treating physician planned to evaluate patient medication and follow up with the device following physician.At this time, the device system remains in-service.No adverse patient effects were reported.

• Brand Name: MOMENTUM X4 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: 16240035
• MDR Text Key: 308079586
• Report Number: 2124215-2023-02850
• 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
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/04/2022
• Device Model Number: G138
• Device Catalogue Number: G138
• Device Lot Number: 386115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2020
• 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
• Patient Age: 69 YR
• Patient Sex: Male