MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G138

Device Problems High impedance (1291); Data Problem (3196); High Capture Threshold (3266)

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

Event Date 03/21/2024

Event Type  malfunction  

Event Description

It was reported that this implantable cardiac resynchronization therapy defibrillator (crt-d) exhibited increased threshold measurements in daily measurement checks, and boston scientific technical services (ts) was contacted to explain why this did not trigger a yellow alert.However, upon data review, it was confirmed that the device was operating appropriately, and the alert function was explained.Additionally, yellow alerts for elevated, out-of-range right atrial (ra) pacing impedance measurements (>3000 ohms).Ts also noted elevated right ventricular (rv) lead threshold measurements and recommended assessing both the ra and rv leads in-clinic.At this time, the system remains implanted and in-service.No adverse patient effects were reported.

Event Description

It was reported that this implantable cardiac resynchronization therapy defibrillator (crt-d) exhibited increased threshold measurements in daily measurement checks, and boston scientific technical services (ts) was contacted to explain why this did not trigger a yellow alert.However, upon data review, it was confirmed that the device was operating appropriately, and the alert function was explained.Additionally, yellow alerts for elevated, out-of-range right atrial (ra) pacing impedance measurements (>3000 ohms).Ts also noted elevated right ventricular (rv) lead threshold measurements and recommended assessing both the ra and rv leads in-clinic.However, it was later confirmed that the patient does not have an active ra lead.The patient presented for a follow-up appointment, where the auto-threshold feature was found to not be working.However, manual threshold testing was successful and showed normal threshold measurements.The physician elected to reprogram the device to manual output and continue with normal follow-up appointments.At this time, the system remains implanted and in-service.No adverse patient effects were reported.

• Brand Name: MOMENTUM X4 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: 19085072
• MDR Text Key: 340106484
• Report Number: 2124215-2024-21999
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

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: G138
• Device Catalogue Number: G138
• Device Lot Number: 393577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1