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

Model Number G447

Device Problem High impedance (1291)

Patient Problem Chest Pain (1776)

Event Date 06/02/2023

Event Type  Injury  

Event Description

It was reported that the patient contacted latitude customer support because their remote communicator's dongle was red.It was explained that the dongle indicates the communicator is connected to the internet.The patient stated that they were having chest pains around the device implant location and it was recommended to go to the emergency room.Upon further device data review, a high, out-of-range pacing impedance measurement (>3000 ohms) was noted from the right atrial (ra) lead.It was determined that there was actually no atrial lead implanted and this information was provided to the field representative to program off the atrial lead monitoring.At this time, the device remains implanted and in-service.Information has been requested regarding the current patient status and event resolution, but a response has not yet been received.

• Brand Name: RESONATE X4 CRT-D
• 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: 17204774
• MDR Text Key: 317899601
• Report Number: 2124215-2023-33212
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/26/2023

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 Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 290651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other