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

Model Number G447

Device Problem Data Problem (3196)

Patient Problems Dyspnea (1816); Fatigue (1849)

Event Date 11/22/2022

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced symptoms and thinks related to implantable device.Additional information from the field representative was obtained which indicated that the patient has not been checked and a remote transmission was received two months ago and revealed that the device was normally functioning.This device remains in service.No adverse patient effects were reported.Additional information received two years after, indicating patient stated that the device was disabled.Also, the patient was experiencing getting out of breath going from bed to bathroom and would take up to two to three hours of bedrest to recover.The patient could not stand very long without being short of breath and fatigue.Attempts to obtain further information from the field was unsuccessful.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESONATE X4 CRT-D
• Type of Device: IMPLANTABLE DEVICE
• 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: 18806912
• MDR Text Key: 336551589
• Report Number: 2124215-2024-12181
• Device Sequence Number: 1
• Product Code: NIK
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/10/2020
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 195955
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2018
• 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 Age: 62 YR
• Patient Sex: Female