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

Model Number G447

Device Problems Failure to Capture (1081); Inaccurate Synchronization (1609); Unexpected Therapeutic Results (1631); Under-Sensing (1661)

Patient Problems Arrhythmia (1721); Ventricular Fibrillation (2130)

Event Date 09/28/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was having a right atrial automatic threshold test.At the end of the test there was loss of capture at two beats with subsequent atrial sensing, left ventricular (lv) pacing and then a blanked right ventricular sensing.There was consistent morphology of captured lv pacing beats.Then a premature ventricular contraction appears to initiate a ventricular tachycardia (vt), furthermore, an anti-tachycardia pacing appears to accelerate the rhythm to ventricular fibrillation.An electric shock failed to convert but slowed the rhythm to a vt.Finally, a subsequent electric shock successfully terminated the rhythm.Different programming options were discussed and recommended.The crt-d remains in service.No adverse patient effects were reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was having a right atrial automatic threshold test.At the end of the test there was loss of capture at two beats with subsequent atrial sensing, left ventricular (lv) pacing and then a blanked right ventricular sensing.There was consistent morphology of captured lv pacing beats.Then a premature ventricular contraction appears to initiate a ventricular tachycardia (vt), furthermore, an anti-tachycardia pacing appears to accelerate the rhythm to ventricular fibrillation.An electric shock failed to convert but slowed the rhythm to a vt.Finally, a subsequent electric shock successfully terminated the rhythm.Different programming options were discussed and recommended.Several months later it was reported that lv pacing percentage had decreased but it was related to a patient condition of ectopy.Also, it was discussed that the device had been reprogrammed to resolve the situation that occurred some months before.Furthermore, new programming options were recommended in order to resolve the lv pacing percentage decrease.The crt-d remains in service.No adverse patient effects were reported.

• Brand Name: RESONATE X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: 17962438
• MDR Text Key: 326004577
• Report Number: 2124215-2023-58019
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/20/2023
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 274832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2022
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male