MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number G138

Device Problems Failure to Capture (1081); Pacing Problem (1439); Connection Problem (2900)

Patient Problem Asystole (4442)

Event Date 11/06/2023

Event Type  Injury  

Event Description

It was reported that during a cardiac resynchronization therapy defibrillator (crt-d) replacement procedure a new crt-d was attempted with the already in service right ventricular (rv), right atrial (ra) and left ventricular (lv) leads.After two minutes of appropriate pacing, loss of capture (loc) with brady pacing not delivered as expected was observed and the patient went asystolic less than 2 seconds.They reprogrammed the device to electrocautery mode and capture was observed.They kept testing the leads and thought it was header issue, so they tried a new crt-d.With this new crt-d all three leads were connected, and a similar behavior occurred after some minutes where the patient went asystolic again.Also, they went to cautery mode and capture was observed.The physician opted to cut and abandon a portion of the rv lead.The other portion has been returned for analysis.A new rv lead was implanted with a new crt-d.The explanted and attempted crt-ds have been returned for analysis.No additional adverse patient effects were reported.

Manufacturer Narrative

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

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cardiac resynchronization therapy defibrillator (crt-d) replacemente procedure a new crt-d was attempted with the already in service right ventricular (rv), right atrial (ra) and left ventricular (lv) leads.After two minutes of appropriate pacing, loss of capture (loc) with brady pacing not delivered as expected was observed and the patient went asystolic less than 2 seconds.They reprogrammed the device to electrocautery mode and capture was observed.They kept testing the leads and thought it was header issue, so they tried a new crt-d.With this new crt-d all three leads were connected, and a similar behavior occurred after some minutes where the patient went asystolic again.Also, they went to cautery mode and capture was observed.The physician opted to cut and abandon a portion of the rv lead.The other portion has been returned for analysis.A new rv lead was implanted with a new crt-d.The explanted and attempted crt-ds have been returned for analysis.No additional adverse patient effects were reported.

• Brand Name: MOMENTUM X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY 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: 18208282
• MDR Text Key: 328958185
• Report Number: 2124215-2023-66719
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589188
• UDI-Public: 00802526589188
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G138
• Device Catalogue Number: G138
• Device Lot Number: 393552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2023
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male