MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G124

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Defibrillation/Stimulation Problem (1573); High Capture Threshold (3266)

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

Event Date 08/21/2023

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded an alert for anti-tachycardia pacing (atp) therapy delivered to convert arrhythmia.It was then determined that the atp therapy was appropriate.Far-field r-wave oversensing was observed throughout the episode, resulting in incorrect rhythm classification and possible delay to therapy.The right ventricular (rv) lead pacing impedance was also noted to have increased, however, it remains within normal range.In-clinic assessment was recommended.The crt-d system remains in service.No adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded an alert for anti-tachycardia pacing (atp) therapy delivered to convert arrhythmia.It was then determined that the atp therapy was appropriate.Far-field r-wave oversensing was observed throughout the episode, resulting in incorrect rhythm classification and possible delay to therapy.The right ventricular (rv) lead pacing impedance was also noted to have increased, however, it remains within normal range.In-clinic assessment was recommended.Additional information was provided.Further changes in the rv lead impedance show an increase to a maximum of 1328 ohms, which is high out of range.A recent increase in the rv capture threshold was also observed.The rv electrogram (egm) baseline seems slightly noisy but there is no oversensing observed in any egm.Ts recommended to continue to monitor.The crt-d system remains in service.No adverse patient effects were reported.

• Brand Name: MOMENTUM CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH 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: 17666904
• MDR Text Key: 322540581
• Report Number: 2124215-2023-47318
• Device Sequence Number: 1
• Product Code: NIK
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• 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: 513598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR