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

Model Number G156

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Failure to Read Input Signal (1581); High Capture Threshold (3266)

Patient Problem Bradycardia (1751)

Event Date 11/10/2023

Event Type  malfunction  

Event Description

It was reported that the patient with cardiac resynchronization therapy defibrillator (crt-d) device exhibited out of range amplitude.Upon review, there were no noise and impedance measurements were stable.Myopotential testing was performed, and no low r waves were seen.The patient had some premature ventricular contraction (pvc).The non-boston scientific right atrial (ra) lead thresholds were noted.It was noted that when the ra threshold testing was performed, the device stopped pacing.However further review of latitude showed some v episodes and atrial tachy response (atr) episodes with noise on all, likely due to electromagnetic interference (emi).The patient underwent heart surgery few months back and there was significant dropped in the p waves.The plant was to perform an x-ray and further discuss with the physician.This device and non-boston scientific leads remains in service.No adverse patient 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: 18173123
• MDR Text Key: 328630584
• Report Number: 2124215-2023-65413
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534669
• UDI-Public: 00802526534669
• 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
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/10/2020
• Device Model Number: G156
• Device Catalogue Number: G156
• Device Lot Number: 379236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2018
• 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 Age: 76 YR
• Patient Sex: Male