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

Model Number G447

Device Problem Inaccurate Synchronization (1609)

Patient Problem Atrial Fibrillation (1729)

Event Date 03/04/2022

Event Type  Injury  

Event Description

It was reported that this patient suffered a syncopal episode, and a review of this event was requested.Technical services reviewed the data and discussed that detection and therapy delivery indicate appropriate device behavior based on design and programming.The mentioned syncope was due to a ventricular arrhythmia.In addition, ts recommended to shorten the duration for ventricular fibrillation zone to 1 second.Anti-tachycardia pacing (atp) was not delivered as rate was measured over 250 bpm.It appears that the appropriate delivered shock initiated an episode of atrial fibrillation.This cardiac resynchronization therapy defibrillator remains in service and no additional adverse patient effects were reported.

• Brand Name: RESONATE X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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: 14068346
• MDR Text Key: 288998355
• Report Number: 2124215-2022-07986
• 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
• Report Date: 04/09/2022

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: 09/04/2021
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 224392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 04/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2019
• 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
• Patient Age: 61 YR
• Patient Sex: Male