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

Model Number G158

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)

Patient Problem Syncope/Fainting (4411)

Event Date 01/04/2024

Event Type  Injury  

Event Description

It was reported that this patient underwent an ablation procedure.During the procedure the patient experienced syncope and it had to be stopped.Upon review of this cardiac resynchronization therapy defibrillator (crt-d) device data, there were stored episodes which coincided with the procedure due to the electromagnetic interference (emi) noise and oversensing which resulted in up to three seconds of pacing inhibition.This patient is pacing dependent.A magnet was confirmed to be used during the procedure.No additional adverse patient effects were reported.Currently, this crt-d remains in service.

• Brand Name: DYNAGEN 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: 18630787
• MDR Text Key: 334431786
• Report Number: 2124215-2024-05881
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2024

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: 10/27/2020
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 202747
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2018
• 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: 78 YR
• Patient Sex: Female