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

Model Number G124

Device Problem Inaccurate Synchronization (1609)

Patient Problem Ventricular Fibrillation (2130)

Event Date 03/02/2024

Event Type  Injury  

Event Description

It was reported that the patient appropriately received anti-tachycardia pacing (atp) and shock therapy to convert a ventricular arrhythmia.After successive rounds of burst atp that did not convert the rhythm, the cardiac resynchronization therapy defibrillator (crt-d) delivered ramp atp that appeared to accelerate the rhythm into the programmed ventricular fibrillation zone.One 41 joule shock then converted the rhythm.Technical services recommended further review of the programmed settings.The crt-d remains in service and no adverse patient effects were reported.

Event Description

It was reported that the patient appropriately received anti-tachycardia pacing (atp) and shock therapy to convert a ventricular arrhythmia.After successive rounds of burst atp that did not convert the rhythm, the cardiac resynchronization therapy defibrillator (crt-d) delivered ramp atp that appeared to accelerate the rhythm into the programmed ventricular fibrillation zone.One 41 joule shock then converted the rhythm.Technical services recommended further review of the programmed settings.The crt-d remains in service and no adverse patient effects were reported.Additional information received indicated that further instances of rhythm acceleration occurred.In one instance, the rhythm was initially detected in the programmed vt-1 zone at 179 beats/minute.Atp was delivered and the rhythm accelerated into the vt zone.Four additional rounds of atp then accelerated the rhythm into the vf zone.Subsequently, one 41 joule shock successfully terminated arrhythmia.In another instance, the rhythm was detected at 165 beats/minute.Five rounds of atp were delivered after which the rhythm accelerated into the vt zone and was subsequently terminated with additional atp.In the most recent instance, a total of ten bursts of atp were delivered with unsuccessful conversion and the rhythm accelerated.The arrhythmia continued for approximately four minutes with some intervals falling back into the programmed vt-1 zone.Further review of the programmed settings was recommended.

• Brand Name: MOMENTUM CRT-D
• Type of Device: IMPLANTABLE DEVICE
• 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: 18963578
• MDR Text Key: 338396313
• Report Number: 2124215-2024-17569
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/04/2024
• Device Model Number: G124
• Device Catalogue Number: G124
• Device Lot Number: 508969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• 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