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

Model Number G158

Device Problems Signal Artifact/Noise (1036); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Under-Sensing (1661)

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

Event Date 01/19/2024

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) device was in ventricular tachycardia (vt) storm.The patient received inappropriate shocks and anti-tachycardia pacing (atp).There was a signal artifact monitor (sam) episode noted and noise was seen on the right atrial (ra) channel.Upon review, the therapy was given in ventricular tachycardia (vt) due to ventricular was greater than the atrial.The patient was intubated and not well.There was undersensing seen during the atrial fibrillation (af).Technical services (ts) recommended programming options.The patient was in a vt storm and needed to be managed medically to stabilize them.This device remains in service.No additional patient adverse effects were reported.

• Brand Name: DYNAGEN X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (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: 18624450
• MDR Text Key: 334337190
• Report Number: 2124215-2024-05674
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534904
• UDI-Public: 00802526534904
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 294566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• 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; Other
• Patient Age: 83 YR
• Patient Sex: Male