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

Model Number G447

Device Problems Premature Discharge of Battery (1057); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)

Patient Problem Electric Shock (2554)

Event Date 01/23/2023

Event Type  malfunction  

Manufacturer Narrative

This product remains implanted and has not been returned.As such, physical analysis has not been conducted in our laboratory.As no further information concerning this report is expected our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that the patient with a cardiac resynchronization therapy defibrillator (crt-d) device received 1 inappropriate shock due to atrial fibrillation (af).The patient went to the emergency room.The physician reported that the fast conducted af is due to patient being non-complaint with medication.The physician reported an increase in battery consumption of the last year.Device was reprogrammed to vvi and the atrial lead is switched off due to increased battery consumption.The device remains implanted.No adverse patient effects were reported.Additional information was received that the patient is scheduled for an ablation and device revision in the near future.Engineering reviewed device data and confirmed device is depleting normally.The power consumption is within expectations based on programmed parameters and therapy delivery.The device remains implanted at this time no adverse patient effects were reported.

Event Description

It was reported that the patient with a cardiac resynchronization therapy defibrillator (crt-d) device received 1 inappropriate shock due to atrial fibrillation (af).The patient went to the emergency room.The physician reported that the fast conducted af is due to patient being non-complaint with medication.The physician reported an increase in battery consumption of the last year.Device was reprogrammed to vvi and the atrial lead is switched off due to increased battery consumption.The device remains implanted.No adverse patient effects were reported.Additional information was received that the patient is scheduled for an ablation and device revision in the near future.Engineering reviewed device data and confirmed device is depleting normally.The power consumption is within expectations based on programmed parameters and therapy delivery.The device remains implanted at this time.No adverse patient effects were reported.

Manufacturer Narrative

This product remains implanted.Technical service device data analysis confirmed normal power consumption, no faults.As such, physical analysis has not been conducted in our laboratory.As no further information concerning this report is expected our investigation is complete.This investigation will be updated should further information be provided.

• 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: 16354216
• MDR Text Key: 309377017
• Report Number: 2124215-2023-05995
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589539
• UDI-Public: 00802526589539
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/14/2019
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 165691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1