MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; IMPLANTABLE DEFIBRILLATOR

Model Number G447

Device Problems Failure to Convert Rhythm (1540); Under-Sensing (1661)

Patient Problem Ventricular Fibrillation (2130)

Event Date 02/28/2023

Event Type  Injury  

Event Description

It was reported, that the patient with this cardiac resynchronization therapy defibrillator (crt-d).Entered in an intrinsic ventricular tachycardia episode.The device appropriately delivered anti tachy pacing (atp) and shocks.However, they were unsuccessful.The rhythm accelerated into a ventricular fibrillation.Which was initially undersensed.Which made the first attempt to deliver a shock for the ventricular fibrillation to be aborted.Eventually, a second attempt was performed.And a shock was delivered by the device which ended the episode.Reprograming of the device and defibrillator threshold (dft) test were discussed.This device remains in service.No further adverse patient effects were reported.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) entered in an intrinsic ventricular tachycardia episode.The device appropriately delivered anti tachy pacing (atp) and shocks, however they were unsuccessful.The rhythm accelerated into a ventricular fibrillation which was initially undersensed.Which made the first attempt to deliver a shock for the ventricular fibrillation to be aborted.Eventually, a second attempt was performed and a shock was delivered by the device which ended the episode.Reprograming of the device and defibrillator threshold (dft) test were discussed.This device remains in service.No further adverse patient effects were reported.

• Brand Name: RESONATE X4 CRT-D
• Type of Device: IMPLANTABLE 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: 17043032
• MDR Text Key: 316409408
• Report Number: 2124215-2023-27905
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589539
• UDI-Public: 00802526589539
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S436
• 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: 06/02/2023

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: 06/15/2023
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 262691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 05/12/2023
• Supplement Dates FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• 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: 59 YR
• Patient Sex: Male