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

Model Number G126

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Unspecified Infection (1930); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 10/07/2022

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) system exhibited infection.Reportedly, the right ventricular (rv) lead was explanted successfully, nonetheless, while performing the left ventricular (lv) lead extraction, the lead was fractured and the coil unraveled; hence, the lv lead was abandoned for the time being.Moreover, after explanting the right atrial (ra) lead, the anesthesiologist noticed an effusion in the right atrium and a cardiopulmonary resuscitation (cpr) was performed as the patient exhibited cardiac arrest.An open-heart procedure was done to fix the effusion.There were no additional adverse patient effects reported.This explanted device will not be returned.

• Brand Name: MOMENTUM CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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: 15617638
• MDR Text Key: 301859512
• Report Number: 2124215-2022-41827
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589140
• UDI-Public: 00802526589140
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/24/2024
• Device Model Number: G126
• Device Catalogue Number: G126
• Device Lot Number: 106468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2022
• 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; Required Intervention; Life Threatening
• Patient Age: 84 YR
• Patient Sex: Female