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

Model Number G447

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Use of Device Problem (1670)

Patient Problem Electric Shock (2554)

Event Date 06/20/2022

Event Type  Injury  

Event Description

It was reported that during a radio frequency ablation (rfa) procedure, this cardiac resynchronization therapy defibrillator (crt-d) delivered a shock to the patient while a magnet was placed over the device.Review of remote monitoring data noted that the patient had a magnetic resonance imaging (mri) and they would not hear audible tones, as the beeper was disabled.It was verified that the magnet response was set to inhibit therapy.It was likely that the magnet was not over the device correctly, given the patient's prone position.The field representative programmed therapy off for the rest of the procedure, and planned to turn it back on once the procedure was completed.This crt-d remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

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

Event Description

It was reported that during a radio frequency ablation (rfa) procedure, this cardiac resynchronization therapy defibrillator (crt-d) delivered a shock to the patient while a magnet was placed over the device.Review of remote monitoring data noted that the patient had a magnetic resonance imaging (mri) and they would not hear audible tones, as the beeper was disabled.It was verified that the magnet response was set to inhibit therapy.It was likely that the magnet was not over the device correctly, given the patient's prone position.The field representative programmed therapy off for the rest of the procedure, and planned to turn it back on once the procedure was completed.This crt-d remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

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

• 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: 14847348
• MDR Text Key: 294911645
• Report Number: 2124215-2022-23347
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

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: Health Professional
• Device Expiration Date: 03/30/2023
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 257575
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 06/28/2022
• Supplement Dates Manufacturer Received: 09/12/2022
• Supplement Dates FDA Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male