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

Model Number G138

Device Problems Over-Sensing (1438); Pacing Problem (1439); Defibrillation/Stimulation Problem (1573); Under-Sensing (1661)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited crosstalk oversensing of atrial signals on the ventricular channel.As a result, there was pacing inhibition.There are no reports of asystole as the patient is not dependent.Additionally, there was undersensing of a fine ventricular fibrillation (vf) event, which resulted in a delay of therapy.Technical services (ts) reviewed the reports and provided reprogramming options.The device remains in use.No additional adverse patient effects were reported.

• Brand Name: MOMENTUM X4 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 ; 6515826168
• MDR Report Key: 18466541
• MDR Text Key: 332332249
• Report Number: 2124215-2024-00630
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/11/2024
• Device Model Number: G138
• Device Catalogue Number: G138
• Device Lot Number: 389703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2022
• 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 Age: 76 YR
• Patient Sex: Male