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

Model Number G158

Device Problems Defibrillation/Stimulation Problem (1573); Failure to Select Signal (1582); Under-Sensing (1661)

Patient Problems Cardiac Arrest (1762); Ventricular Fibrillation (2130)

Event Date 06/25/2019

Event Type  Injury  

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited intermittent undersensing of ventricular fibrillation (vf), causing the rhythm to be detected as ventricular tachycardia (vt) in the monitor only zone.The patient went into cardiac arrest and required external shock therapy and cardiopulmonary resuscitation.The patient was noted to have been placed in the intensive care unit following the episode as they were also recovering from an unrelated surgical procedure at the time of the episode.Review of the stored episodes noted that the automatic gain control feature was programmed on and the amplitudes appeared to be varied in a tall/short pattern making it difficult to be detected.The physician initially made programming changes to the therapy zones and duration, however, a few days later, an invasive procedure was performed.The device was explanted and replaced with another manufacturer's device.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.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 analysis of this device was completed.

• 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
• MDR Report Key: 9097317
• MDR Text Key: 175255675
• Report Number: 2124215-2019-17546
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534904
• UDI-Public: 00802526534904
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/05/2018
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 158679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR