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

Model Number G158

Device Problems Failure to Convert Rhythm (1540); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 10/25/2023

Event Type  Injury  

Event Description

It was reported that a review of therapy delivery was requested for this cardiac resynchronization therapy defibrillator (crt-d).This device delivered 8 shocks, exhausting therapy without breaking the arrhythmia.The health care professional (hcp) requested a review of the therapy and an explanation for a shorter charge time for one of the shocks.Technical services (ts) reviewed the event data and agreed with the hcp that the event appeared to be mix of atrial driven and ventricular arrhythmias.This led to a series of shocks as well as diverted attempts due to failure to reconfirm the ventricular arrhythmia.Due to device programming a shock cannot be diverted more than once, possibly resulting in shocks delivered for atrial driven rhythms.The stored energy in the capacitors from the charge cycle prior to the diverted shock, led to the shorter charge time on the specifically noted shock.The patient was referred to the emergency room (er) by the hcp as at the arrhythmia was persistent at the time of the call.The patient was later admitted to the hospital and medication was administered.The device shocking feature was temporarily disabled during treatment.Subsequently the patient was discharged and the device setting reviewed by a healthcare professional.This device remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The device was exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that a review of therapy delivery was requested for this cardiac resynchronization therapy defibrillator (crt-d).This device delivered 8 shocks, exhausting therapy without breaking the arrhythmia.The health care professional (hcp) requested a review of the therapy and an explanation for a shorter charge time for one of the shocks.Technical services (ts) reviewed the event data and agreed with the hcp that the event appeared to be mix of atrial driven and ventricular arrhythmias.This led to a series of shocks as well as diverted attempts due to failure to reconfirm the ventricular arrhythmia.Due to device programming a shock cannot be diverted more than once, possibly resulting in shocks delivered for atrial driven rhythms.The stored energy in the capacitors from the charge cycle prior to the diverted shock, led to the shorter charge time on the specifically noted shock.The patient was referred to the emergency room (er) by the hcp as at the arrhythmia was persistent at the time of the call.The patient was later admitted to the hospital and medication was administered.The device shocking feature was temporarily disabled during treatment.Subsequently the patient was discharged and the device setting reviewed by a healthcare professional.This device remains in service.No additional adverse patient effects were reported.This device was subsequently explanted due to normal battery depletion and returned for analysis.

• 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: 18133887
• MDR Text Key: 328078659
• Report Number: 2124215-2023-64060
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

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: 11/17/2017
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 141908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2015
• 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; Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male