RESONATE X4 CRT-D
Report
- Report Number
- 2124215-2025-49367
- Event Type
- Injury
- Date Received
- July 22, 2025
- Date of Event
- July 18, 2025
- Report Date
- March 25, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIK
- UDI-DI
- 00802526603938
- PMA / PMN Number
- P010012/S436
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTION TO FIELD H6: PATIENT CODES. UPDATED TO E060110 VENTRICULAR FIBRILLATION.
THIS PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS AS IT REMAINS IN SERVICE. SINCE THE REPORTED ISSUES ARE COVERED BY THE INSTRUCTIONS FOR USE, IT CAN BE CONCLUDED THAT EXPECTED OR WELL-UNDERSTOOD FACTORS MOST PROBABLY CONTRIBUTED TO THE EVENT. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE OR IF ANALYSIS IS COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THE REVIEW OF THE DHR IDENTIFIED THAT THERE WERE NO PROCESS RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING THE PRODUCTION THAT COULD EXPLAIN THE EVENT. THE REVIEWS ENSURE EACH DEVICE MEETS SPECIFICATION PRIOR TO RELEASE FOR USE. THERE IS NO INDICATION THE DEVICE MANUFACTURING PROCESS CONTRIBUTED TO THE REPORTED COMPLAINT. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF RHYTHM ACCELERATION WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. REVIEW OF LABELING DETERMINED THAT THE COMPLAINT SITUATION WAS LISTED IN THE MANUAL. THERE WAS NO INDICATION IN THE COMPLAINT THAT THE PRODUCT WAS NOT USED IN ACCORDANCE TO LABELING. THE MANUAL WAS UNLIKELY TO BE THE CAUSE OF THE REPORTED COMPLAINT; TRANSLATION, WORDING, OR GRAPHICS DOES NOT REQUIRE FURTHER REVIEW. THIS DEVICE REMAINS IMPLANTED AND IN-SERVICE AND SO HAS NOT BEEN RETURNED. AS SUCH, PHYSICAL ANALYSIS HAS NOT BEEN CONDUCTED IN OUR LABORATORY. HOWEVER, ANALYSIS OF THE AVAILABLE INFORMATION DETERMINED THAT THE RHYTHM ACCELERATION AND FAILURE TO CAPTURE ARE A KNOWN INHERENT RISK WITH USE OF THIS PRODUCT.
IT WAS REPORTED THAT DURING AN EPISODE OF VENTRICULAR TACHYCARDIA (VT), ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). NON-CAPTURE WAS OBSERVED AND THE ARRHYTHMIA INTERVALS ACCELERATED INTO THE VENTRICULAR FIBRILLATION (VF) ZONE. THE CRT-D DELIVERED A SHOCK WHICH SUCCESSFULLY CONVERTED THE ARRHYTHMIA. THE CRT-D SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT DURING AN EPISODE OF VENTRICULAR TACHYCARDIA (VT), ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). NON-CAPTURE WAS OBSERVED AND THE ARRHYTHMIA INTERVALS ACCELERATED INTO THE VENTRICULAR FIBRILLATION (VF) ZONE. THE CRT-D DELIVERED A SHOCK WHICH SUCCESSFULLY CONVERTED THE ARRHYTHMIA. THE CRT-D SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT DURING AN EPISODE OF VENTRICULAR TACHYCARDIA (VT), ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). NON-CAPTURE WAS OBSERVED AND THE ARRHYTHMIA INTERVALS ACCELERATED INTO THE VENTRICULAR FIBRILLATION (VF) ZONE. THE CRT-D DELIVERED A SHOCK WHICH SUCCESSFULLY CONVERTED THE ARRHYTHMIA. THE CRT-D SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1938370 | RESONATE X4 CRT-D | IMPLANTABLE DEVICE | NIK | BOSTON SCIENTIFIC CORPORATION | G447 | 328221 | 00802526603938 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Unknown | Life Threatening |