MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN X4 CRT-D; IMPLANTABLE DEVICE

Model Number G158

Device Problem Inaccurate Synchronization (1609)

Patient Problems Arrhythmia (1721); Fall (1848); Electric Shock (2554); Syncope/Fainting (4411)

Event Date 10/11/2023

Event Type  Injury  

Event Description

It was reported that the biventricular (biv) pacing feature of this cardiac resynchronization therapy defibrillator (crt-d) induced this patient into a ventricular tachycardia (vt) arrhythmia.Quick convert was provided however, it did not successfully break the rhythm.During the charge the rhythm broke, and the shock was diverted.The biv pacing once again induced this patient back into vt.It appears that the rhythm had broken at the end of the charge however the shock was already committed therefore, was delivered.It was noted that this patient went in and out of vt, receiving a total of two shocks.Additionally, this patient experienced syncope and fell, hitting their head.The health care professional (hcp) will program the biv feature off.At this time, the device remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

Correction to field h6 (impact codes).

Event Description

It was reported that the biventricular (biv) pacing feature of this cardiac resynchronization therapy defibrillator (crt-d) induced this patient into a ventricular tachycardia (vt) arrhythmia.Quick convert was provided however, it did not successfully break the rhythm.During the charge the rhythm broke, and the shock was diverted.The biv pacing once again induced this patient back into vt.It appears that the rhythm had broken at the end of the charge however the shock was already committed therefore, was delivered.It was noted that this patient went in and out of vt, receiving a total of two shocks.Additionally, this patient experienced syncope and fell, hitting their head.The health care professional (hcp) will program the biv feature off.At this time, the device remains in service.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN X4 CRT-D
• Type of Device: IMPLANTABLE DEVICE
• 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: 17980132
• MDR Text Key: 326233575
• Report Number: 2124215-2023-58429
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/22/2019
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 184679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2018
• 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; Life Threatening
• Patient Age: 42 YR
• Patient Sex: Male