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

Model Number G124

Device Problems Failure to Capture (1081); High Capture Threshold (3266); Interrogation Problem (4017)

Patient Problem Asystole (4442)

Event Date 01/17/2023

Event Type  malfunction  

Event Description

It was reported that after an av node ablation, during a threshold test, loss of capture was observed, resulting in asystole of up to 3.3 seconds.Boston scientific technical services helped troubleshoot the issues.Later, another threshold test was performed with a different programmer and there were no issues.Ts noted the issue was likely a telemetry issue.The device remains in service.No adverse patient effects were reported.

Event Description

It was reported that after an av node ablation, during a threshold test, loss of capture was observed, resulting in asystole of up to 3.3 seconds.Boston scientific technical services (ts) helped troubleshoot the issues.Later, another threshold test was performed with a different programmer and there were no issues.Ts noted the issue was likely a telemetry issue.The device remains in service.No adverse patient effects were reported.Additional information was received that the device was explanted and replaced due to normal battery depletion.The right ventricular (rv) lead was surgically abandoned and replaced along with the device.No adverse patient effects were reported.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: MOMENTUM CRT-D
• Type of Device: IMPLANTABLE DEVICE
• 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: 16231087
• MDR Text Key: 308009832
• Report Number: 2124215-2023-02577
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

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 Model Number: G124
• Device Catalogue Number: G124
• Device Lot Number: 513357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 01/23/2023
• Supplement Dates Manufacturer Received: 11/09/2023
• Supplement Dates FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2022
• 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: 73 YR
• Patient Sex: Male