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

Model Number G156

Device Problems Pacing Problem (1439); Inaccurate Synchronization (1609); Under-Sensing (1661)

Patient Problem Ventricular Fibrillation (2130)

Event Date 11/01/2023

Event Type  Injury  

Event Description

It was reported that there were concerns that this cardiac resynchronization therapy defibrillator (crt-d) delivered inappropriate therapy and triggered a ventricular arrhythmia.Technical services (ts) reviewed the event data and noted that this device appeared to deliver inappropriate anti-tachycardia pacing (atp) as a result of an atrial arrhythmia.There was evidence of functional undersensing of the atrial rhythm which contributed to the treatment decision.The atp appeared to trigger ventricular fibrillation (vf) which was then successfully terminated by an appropriate shock.Device reprogramming options were discussed with the health care professional (hcp).This device remains in service.No additional adverse patient effects were reported.

Event Description

It was reported that there were concerns that this cardiac resynchronization therapy defibrillator (crt-d) delivered inappropriate therapy and triggered a ventricular arrhythmia.Technical services (ts) reviewed the event data and noted that this device appeared to deliver inappropriate anti-tachycardia pacing (atp) as a result of an atrial arrhythmia.There was evidence of functional undersensing of the atrial rhythm which contributed to the treatment decision.The atp appeared to trigger ventricular fibrillation (vf) which was then successfully terminated by an appropriate shock.Device reprogramming options were discussed with the health care professional (hcp).This device remains in service.No additional adverse patient effects were reported.Further information was received indicating a concern of possible pacemaker mediated tachycardia (pmt).Ts reviewed the declared episode and noted that it appeared the event was more likely a result of sinus driven rhythm rather than true pmt.Possible device reprogramming options were provided.

Manufacturer Narrative

This report contains a correction to field h6: impact codes to include an additional code.

Event Description

It was reported that there were concerns that this cardiac resynchronization therapy defibrillator (crt-d) delivered inappropriate therapy and triggered a ventricular arrhythmia.Technical services (ts) reviewed the event data and noted that this device appeared to deliver inappropriate anti-tachycardia pacing (atp) as a result of an atrial arrhythmia.There was evidence of functional undersensing of the atrial rhythm which contributed to the treatment decision.The atp appeared to trigger ventricular fibrillation (vf) which was then successfully terminated by an appropriate shock.Device reprogramming options were discussed with the health care professional (hcp).This device remains in service.No additional adverse patient effects were reported.Further information was received indicating a concern of possible pacemaker mediated tachycardia (pmt).Ts reviewed the declared episode and noted that it appeared the event was more likely a result of sinus driven rhythm rather than true pmt.Possible device reprogramming options were provided.

• Brand Name: DYNAGEN X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: 18144445
• MDR Text Key: 328224567
• Report Number: 2124215-2023-64453
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/29/2016
• Device Model Number: G156
• Device Catalogue Number: G156
• Device Lot Number: 103431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2014
• 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): Life Threatening; Other
• Patient Age: 78 YR
• Patient Sex: Male