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

Model Number G124

Device Problems Pacing Problem (1439); Inaccurate Synchronization (1609); Under-Sensing (1661)

Patient Problems Arrhythmia (1721); Ventricular Fibrillation (2130)

Event Date 02/22/2024

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited noisy signals on the right ventricular (rv) channel.Additionally, the patient experienced a dual arrhythmia.The device appropriately delivered anti-tachycardia pacing (atp) therapy.However, one atp therapy accelerated the patient's rhythm into a faster ventricular tachycardia (vt).A shock was delivered as a result.The shock failed to convert the rhythm.The rhythm accelerated from a vt to a ventricular fibrillation (vf).Several shocks were delivered, and the rhythm eventually was converted.There was intermittent undersensing of the vf that led to pacing throughout the vf.Technical services (ts) advised following actions.It was noted that the patient was stable and was admitted to the hospital.The device was reprogrammed.The device remains in use.No additional adverse patient effects were reported.

• Brand Name: MOMENTUM CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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 55112-5798 ; 6515826168
• MDR Report Key: 18848800
• MDR Text Key: 337030144
• Report Number: 2124215-2024-13801
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589102
• UDI-Public: 00802526589102
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/25/2022
• Device Model Number: G124
• Device Catalogue Number: G124
• Device Lot Number: 499980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• 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; Life Threatening
• Patient Age: 63 YR
• Patient Sex: Male