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

Model Number G138

Device Problems Failure to Convert Rhythm (1540); Inappropriate/Inadequate Shock/Stimulation (1574); Inaccurate Synchronization (1609)

Patient Problem Electric Shock (2554)

Event Date 01/09/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) delivered inappropriate therapy for atrial fibrillation (af) which was rapidly conducted into the ventricles.On (b)(6) 2023 the patient went into ventricular tachycardia (vt) and therapy was delivered however the shock degraded the rhythm to a fine ventricular fibrillation (vf).The device continued to deliver therapy until exhaustion without conversion.The patient was hospitalized at the time for an unspecified reason and the vf was successfully terminated with an external defibrillator.The patient is currently on extracorporeal membrane oxygenation (ecmo) and possibly has a do not resuscitate order (dnr) in place.The non-boston scientific right ventricular (rv) lead was programmed subthreshold due to high threshold values.

• 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: 16362633
• MDR Text Key: 309387920
• Report Number: 2124215-2023-06194
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/08/2023
• Device Model Number: G138
• Device Catalogue Number: G138
• Device Lot Number: 388809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male