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

Model Number G138

Device Problems Inaccurate Synchronization (1609); Unexpected Therapeutic Results (1631)

Patient Problem Ventricular Fibrillation (2130)

Event Date 08/28/2022

Event Type  Injury  

Manufacturer Narrative

This investigation will be updated should further pertinent information be provided.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) delivered anti-tachycardia pacing (atp) during a ventricular arrhythmia the patient experienced.The atp appears to have accelerated the arrhythmia into a ventricular fibrillation (vf).A shock successfully ended the episode.The crt-d has been programmed with different therapy zones and remains in service.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: 15454810
• MDR Text Key: 300225852
• Report Number: 2124215-2022-36792
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/14/2023
• Device Model Number: G138
• Device Catalogue Number: G138
• Device Lot Number: 388111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• 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; Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Male