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

Model Number G138

Device Problems Failure to Convert Rhythm (1540); Under-Sensing (1661); Data Problem (3196)

Patient Problem Cardiac Arrest (1762)

Event Date 02/22/2023

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced cardiac arrest.Boston scientific technical services (ts) was consulted and upon review, it was noted that the event started as a rapid atrial fibrillation (af) that progressed into the ventricular tachycardia (vt) zone under the detection rate which failed to convert the episode.The device delivered anti-tachycardia pacing (atp) and an electric shock that successfully converted the rhythm.Reprogramming options were discussed, and further testing was recommended for device optimization.Additional information from the field representative confirmed the physician suspected the device undersensed the ventricular fibrillation (vf).No additional adverse patient effects were reported.At this time, this device system remains in service.

• Brand Name: MOMENTUM X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY 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: 16977659
• MDR Text Key: 315736119
• Report Number: 2124215-2023-25431
• 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: 05/22/2023

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: 01/17/2024
• Device Model Number: G138
• Device Catalogue Number: G138
• Device Lot Number: 389758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2023
• Initial Date FDA Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• 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): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 63 YR
• Patient Sex: Male