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

Model Number G156

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

Patient Problem Asystole (4442)

Event Date 01/12/2023

Event Type  malfunction  

Event Description

It was reported that there was a stored ventricular episode on this cardiac resynchronization therapy defibrillator (crt-d).Technical services (ts) analyzed device episode data and found that there was oversensing of noise on all channels.There was greater than two seconds of asystole as well as inappropriate anti-tachycardia pacing (atp) delivered.Ts noted that this noise appeared to be due to electromagnetic interference (emi) and recommended further investigation into the cause of the noise.It was confirmed that this patient was performing strenuous activity and around heavy equipment at the time of the episode.All lead measurements appeared to be stable.No adverse patient effects were reported.Currently, this crt-d system 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: 17038402
• MDR Text Key: 316305027
• Report Number: 2124215-2023-27806
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/01/2023

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: 04/04/2019
• Device Model Number: G156
• Device Catalogue Number: G156
• Device Lot Number: 376116
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2017
• 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: 81 YR
• Patient Sex: Male