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

Model Number G138

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Use of Device Problem (1670)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 03/21/2024

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 the patient implanted with this cardiac resynchronization therapy defibrillator (crt-d) was receiving shocks from the device and presented to the hospital.The physician reported that they taped a magnet over the device implant location, however, four shocks were still delivered.Technical services (ts) reviewed the event and discussed why the device diverted and delivered shocks, noting some shocks were properly inhibited by the magnet and others were not, suggesting the magnet was not always in the correct position.The local sales representative later reported that the patient was critically ill and had several comorbidities at the time of this event.The physician determined that the shocks delivered were inappropriate as the patient was in an atrial arrhythmia that conducted to the ventricles.The patient passed away from their illness about eight days later; the physician did not believe that the inappropriate shock therapy caused or contributed to the patient's death.The crt-d was not explanted post-mortem and was not expected to be returned.

• 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: 19175655
• MDR Text Key: 340961476
• Report Number: 2124215-2024-24894
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/23/2022
• Device Model Number: G138
• Device Catalogue Number: G138
• Device Lot Number: 385162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2020
• 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): Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male