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

Model Number G138

Device Problem Inaccurate Synchronization (1609)

Patient Problem Ventricular Fibrillation (2130)

Event Date 04/27/2023

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced a ventricular episode.The device delivered anti-tachycardia pacing (atp) which accelerated the rhythm to a faster morphology.An electric shock was delivered and accelerated the rhythm into a ventricular fibrillation (vf).Eventually, another shock was delivered which successfully converted this episode.Reprogramming options were discussed.No additional adverse patient effects were reported.At this time, this device remains in service.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced a ventricular episode.The device delivered anti-tachycardia pacing (atp) which accelerated the rhythm to a faster morphology.An electric shock was delivered and accelerated the rhythm into a ventricular fibrillation (vf).Eventually, another shock was delivered which successfully converted this episode.Reprogramming options were discussed.Additional information was received that this device has been explanted and replaced.The patient has lung cancer and the tumor is located directly underneath where this device was implanted.The system was moved to the right side to allow for radiation treatment.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: 17043500
• MDR Text Key: 316350272
• Report Number: 2124215-2023-27931
• 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,Followup
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/11/2023
• Device Model Number: G138
• Device Catalogue Number: G138
• Device Lot Number: 387620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• 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 Outcome(s): Life Threatening
• Patient Age: 80 YR
• Patient Sex: Male