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

Model Number G138

Device Problem Failure to Capture (1081)

Patient Problems Undesired Nerve Stimulation (1980); Discomfort (2330)

Event Date 05/08/2023

Event Type  Injury  

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that this device exhibited left ventricular (lv) loss of capture and diaphragmatic stimulation in all vectors.The physician opted to implant a device along with a new left bundle lead.This device was explanted.No additional adverse patient effects were reported.

Event Description

It was reported that this device exhibited left ventricular (lv) loss of capture and diaphragmatic stimulation in all vectors.The physician opted to implant a device along with a new left bundle lead.This device was explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

If pertinent information is provided 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 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: 16988626
• MDR Text Key: 315818941
• Report Number: 2124215-2023-25728
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589188
• UDI-Public: 00802526589188
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/24/2024
• Device Model Number: G138
• Device Catalogue Number: G138
• Device Lot Number: 389805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 05/23/2023
• Supplement Dates Manufacturer Received: 06/28/2023
• Supplement Dates FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2022
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female