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

Model Number G447

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2024

Event Type  malfunction  

Event Description

It was reported that this device was discovered to be in magnetic resonance imaging (mri) protection mode when trying to program for this mode for the patient's mri.Technical services (ts) was consulted on this programming mode and advised the device does not have the capability to automatically revert to mri protection mode when in the presence of a scanner.Ts provided troubleshooting and recommendations for further review to determine when the device was placed in this mode.The representative confirmed the device operated normally during and after the scan.Additional information received advised before the mri scan the device was interrogated and exhibited an alert that the device entered safety mode.The nurse closed the alert and placed the device in mri protection mode for the scan.This is all the information provided, and additional information has been requested.The device remains in service.No adverse patient effects were reported.

Event Description

It was reported that this device was discovered to be in magnetic resonance imaging (mri) protection mode when trying to program for this mode for the patient's mri.Technical services (ts) was consulted on this programming mode and advised the device does not have the capability to automatically revert to mri protection mode when in the presence of a scanner.Ts provided troubleshooting and recommendations for further review to determine when the device was placed in this mode.The representative confirmed the device operated normally during and after the scan.Additional information received advised before the mri scan the device was interrogated and exhibited an alert that the device entered safety mode.The nurse closed the alert and placed the device in mri protection mode for the scan.This is all the information provided, and additional information has been requested.Received additional information the device did not enter safety mode.The leads and device are functioning appropriately after mri protection mode, and no changes were made.There are no patient or device concerns.The device remains in service.No adverse patient effects were reported.

• 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: 18760064
• MDR Text Key: 336202110
• Report Number: 2124215-2024-10647
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 305400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2023
• 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: 74 YR
• Patient Sex: Male