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

Model Number G179

Device Problems Failure to Convert Rhythm (1540); Inaccurate Synchronization (1609)

Patient Problems Arrhythmia (1721); Electric Shock (2554)

Event Date 08/07/2023

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced ventricular tachycardia which was started in the vt zone.Therefore, the device delivered the programmed anti-tachycardia pacing (atp), and there was no impact on the arrythmia.A 1x ramp was delivered, which accelerated the rhythm into the vf zone and the device charged and delivered a 41 joule shock.The rhythm slowed but then sped up again into the vt zone and the device charged, but before shock delivery, the rhythm self-terminated, and the shock was diverted due to a lack of reconfirmation of ongoing arrhythmia.Atrial driven conduction was then seen but before the episode had been declared over, the rhythm begins again before self-terminating.Boston scientific technical services provided programming options such as adjusting the atp that is programmed in the vt zone.Consider increasing the number of scans and reducing the number of ramps could be an option but should be looked at in the context of the patients current clinical condition.The healthcare professional plans to adjust device programming at the next follow-up.No additional adverse patient effects were reported.This device remains in-service.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced ventricular tachycardia which was started in the vt zone.Therefore, the device delivered the programmed anti-tachycardia pacing (atp), and there was no impact on the arrythmia.A 1x ramp was delivered, which accelerated the rhythm into the vf zone and the device charged and delivered a 41 joule shock.The rhythm slowed but then sped up again into the vt zone and the device charged, but before shock delivery, the rhythm self-terminated, and the shock was diverted due to a lack of reconfirmation of ongoing arrhythmia.Atrial driven conduction was then seen but before the episode had been declared over, the rhythm begins again before self-terminating.Boston scientific technical services provided programming options such as adjusting the atp that is programmed in the vt zone.Consider increasing the number of scans and reducing the number of ramps could be an option but should be looked at in the context of the patients current clinical condition.The healthcare professional plans to adjust device programming at the next follow-up.No additional adverse patient effects were reported.This device remains in-service.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Please refer to b5 describe event or problem for more information regarding the specific circumstances of this event.

• Brand Name: AUTOGEN
• 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: 17612495
• MDR Text Key: 321845869
• Report Number: 2124215-2023-45740
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

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: 03/14/2018
• Device Model Number: G179
• Device Catalogue Number: G179
• Device Lot Number: 147092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other