MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Model Number G447

Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Telemetry Discrepancy (1629); Delayed Charge Time (2586)

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

Event Date 01/22/2023

Event Type  Injury  

Event Description

It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.A request was made to have data from this device analyzed.Data analysis showed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.As a result, device replacement within 90 days or more frequent monitoring was recommended.No adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.A request was made to have data from this device analyzed.Data analysis showed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.As a result, device replacement within 90 days or more frequent monitoring was recommended.No adverse patient effects were reported.Additional information was received.This patient had tachy therapy turned off during a routine follow-up, programming was changed to right ventricular (rv) only to help preserve battery, as normal left ventricle function was observed.Later, code 1007 was noted on this crt-d, indicating that the shocking capacitors are not charged to the programmed voltage 45 seconds after the start of charging.Device replacement was recommended.This crt-d remains in-service at this time.This investigation will be updated when further information becomes available.No adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.A request was made to have data from this device analyzed.Data analysis showed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.As a result, device replacement within 90 days or more frequent monitoring was recommended.No adverse patient effects were reported.Additional information was received.This patient had tachy therapy turned off during a routine follow-up, programming was changed to right ventricular (rv) only to help preserve battery, as normal left ventricle function was observed.Later, code 1007 was noted on this crt-d, indicating that the shocking capacitors are not charged to the programmed voltage 45 seconds after the start of charging.Device replacement was recommended.This crt-d remains in-service at this time.This investigation will be updated when further information becomes available.No adverse patient effects were reported.Additional information was received.This crt-d was no longer able to be interrogated due to limited battery capacity.Technical services (ts) recommends replacement and return for analysis.This crt-d remains in-service at this time.No adverse patient effects were reported.Additional information was received.This crt-d was successfully replaced and is expected to be returned to boston scientific for analysis.No additional adverse patient effects were reported.

• Brand Name: RESONATE X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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: 16707182
• MDR Text Key: 312950879
• Report Number: 2124215-2023-16561
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589539
• UDI-Public: 00802526589539
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/04/2019
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 181669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2017
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 74 YR