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

Model Number G124

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); High Capture Threshold (3266)

Patient Problem Asystole (4442)

Event Date 01/06/2023

Event Type  malfunction  

Event Description

It was reported that the right ventricular (rv) lead of this cardiac resynchronization therapy defibrillator (crt-d) system exhibited oversensing of deflections signals, leading into pacing inhibition on the rv channel and an asystole of more than two seconds.It is suspected that deflections are from an old, abandoned lead.The oversensing happened during atrial tachy response (atr) episodes.Additionally, the rv lead exhibited high pacing thresholds and noisy signals in the rv and left ventricular (lv) channel.It was discussed that there were not indicators of a possible header, seal plug or setscrew issue.Technical services (ts) recommended reprogram options.This crt-d remains in service.No 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 ; 6515826168
• MDR Report Key: 16179894
• MDR Text Key: 308590587
• Report Number: 2124215-2023-01531
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589102
• UDI-Public: 00802526589102
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/27/2024
• Device Model Number: G124
• Device Catalogue Number: G124
• Device Lot Number: 509255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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: 81 YR
• Patient Sex: Male