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

Model Number G125

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

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

Event Date 11/28/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited oversensing of noisy signals.The noise was observed on both the right ventricular (rv) and shock electrogram (egm).Shock and pacing impedance trends did not show any abnormalities.A troubleshooting guide was provided to assess lead integrity and exclude any mechanical concerns.No adverse patient effects were reported.The device remains in service.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited oversensing of noisy signals.The noise was observed on both the right ventricular (rv) and shock electrogram (egm).Shock and pacing impedance trends did not show any abnormalities.A troubleshooting guide was provided to assess lead integrity and exclude any mechanical concerns.No adverse patient effects were reported.The device remains in service.Additional information provided from the field indicated surgical intervention was later performed and this device was explanted and replaced.No additional adverse patient effects were reported.The facility made the decision not to return the device for analysis.

• 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: 18406557
• MDR Text Key: 331504883
• Report Number: 2124215-2023-74098
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/29/2023
• Device Model Number: G125
• Device Catalogue Number: G125
• Device Lot Number: 144583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2021
• 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; Required Intervention