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

Model Number G124

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Under-Sensing (1661)

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

Event Date 12/14/2023

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited undersensing on the right atrial channel, it was determined that this was due to the patient experiencing an intrinsic ventricular tachycardia episode in which the atrial and ventricular pacing happened nearly at the same time.Additionally, it also exhibited noise on the right atrial channel and oversensing of the minute ventilation (mv) feature, it was determined that this was due to the therapy delivered by the device for the intrinsic ventricular tachycardia, eventually the noise and mv oversensing resolved on its own.No changes were performed.This device remains in service.No further adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited undersensing on the right atrial channel, it was determined that this was due to the patient experiencing an intrinsic ventricular tachycardia episode in which the atrial and ventricular pacing happened nearly at the same time.Additionally, it also exhibited noise on the right atrial channel and oversensing of the minute ventilation (mv) feature, it was determined that this was due to the therapy delivered by the device for the intrinsic ventricular tachycardia, eventually the noise and mv oversensing resolved on its own.No changes were performed.This device remains in service.No further adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv) sensor that is related to a high impedance condition.Please see the complaint description for more information regarding the specific circumstances of this event.

• Brand Name: MOMENTUM CRT-D
• Type of Device: IMPLANTABLE DEFIBRILLATOR
• 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: 18439922
• MDR Text Key: 331912258
• Report Number: 2124215-2023-75076
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G124
• Device Catalogue Number: G124
• Device Lot Number: 515755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2023
• 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