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

Model Number G138

Device Problems Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Inaccurate Synchronization (1609)

Patient Problem Electric Shock (2554)

Event Date 05/20/2023

Event Type  malfunction  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) delivered therapy due to an atrial fibrillation (af) event with rapid ventricular response.Boston scientific technical services (ts) was consulted and upon review, it was noted that the atrial channel showed af with a variable ventricular rhythm to begin with.The ventricular rhythm became fast and regular enough to fall into the vt zone where it remained sustained long enough for anti-tachycardia pacing (atp) to be delivered.Four bursts of atp were delivered, all of which were unsuccessful.The last burst appears to have accelerated the rhythm into the vf zone where a single 41j shock converted both arrhythmias.No additional adverse patient effects were reported.At this time, this device remains in service.

• Brand Name: MOMENTUM X4 CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER 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: 17065948
• MDR Text Key: 316749909
• Report Number: 2124215-2023-28522
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/05/2023

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 Expiration Date: 01/18/2023
• Device Model Number: G138
• Device Catalogue Number: G138
• Device Lot Number: 387193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2021
• 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: 63 YR
• Patient Sex: Male