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

Model Number G158

Device Problems Inaccurate Synchronization (1609); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Atrial Fibrillation (1729)

Event Date 08/19/2023

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) presented to the er with atrial fibrillation (af) after receiving an electric shock.Technical services (ts) reviewed the device data and noted that this device appropriately delivered a shock for ventricular tachycardia (vt), the therapy successfully broke the vt, however it also resulted in the onset of af.This device remains in service.No additional adverse patient effects were reported.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) presented to the er with atrial fibrillation (af) after receiving an electric shock.Technical services (ts) reviewed the device data and noted that this device appropriately delivered a shock for ventricular tachycardia (vt), the therapy successfully broke the vt, however it also resulted in the onset of af.This device remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

This report contains a correction to field h6:device codes.This correction report is being filed as this complaint was reviewed by the boston scientific medical safety team and it was determined that the cardiac resynchronization therapy defibrillator (crt-d) did not induce the atrial fibrillation (af), as the af began four seconds after the shock was delivered.

• Brand Name: DYNAGEN 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: 17710613
• MDR Text Key: 322950528
• Report Number: 2124215-2023-48952
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534904
• UDI-Public: 00802526534904
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• 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: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/15/2018
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 153415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2016
• 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): Other
• Patient Age: 71 YR
• Patient Sex: Female