RESONATE X4 CRT-D
Report
- Report Number
- 2124215-2022-18556
- Event Type
- Malfunction
- Date Received
- May 26, 2022
- Date of Event
- May 19, 2022
- Report Date
- September 7, 2022
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIK
- UDI-DI
- 00802526589539
- PMA / PMN Number
- P010012/S436
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. THE ASSOCIATED INVESTIGATION DETERMINED THAT THIS DEVICE EXHIBITED INTERMITTENT IMPEDANCE MEASUREMENTS WITH NO CONCLUSIVE EVIDENCE OF A MALFUNCTION OR INADEQUATE LEAD-TO-DEVICE CONNECTION; PLEASE REFER TO THE DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT. INVESTIGATION HAS DETERMINED THAT THIS TYPE OF EVENT IS LIKELY THE RESULT OF AN INTERMITTENT HIGH IMPEDANCE CONDITION ASSOCIATED WITH THE DEVICE SPRING CONTACT AND LEAD TERMINAL RING. A DESIGN ENHANCEMENT WAS IMPLEMENTED IN 2020 TO STABILIZE THE ELECTRICAL CONNECTION BETWEEN THE SPRING CONTACT AND THE LEAD TERMINAL.
IT WAS REPORTED THAT THIS PATIENT UNDERWENT A GENERATOR CHANGE OUT TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE FOLLOWING DAY THERE WAS HIGH OUT OF RANGE PACING IMPEDANCES ON BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD MEASURING GREATER THAN 3000 OHMS. ADDITIONALLY, THE SHOCK LEAD IMPEDANCES (SLI) WERE HIGH OUT OF RANGE MEASURING GREATER THAN 200 OHMS. THE HEALTH CARE PROFESSIONAL (HCP) REACHED OUT TO TECHNICAL SERVICES AND DISK ANALYSIS WAS REQUESTED. THE HCP HAD THE PATIENT PERFORM A PATIENT INITIATED INTERROGATION (PII). THE PRESENTING ELECTROGRAM (EGM) AND ALL LEAD MEASUREMENTS WERE WITHIN NORMAL RANGE. THE PLAN IS TO HAVE THE PATIENT PERFORM ANOTHER PII IN THE FOLLOW WEEK TO CONFIRM MEASUREMENTS. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS PATIENT UNDERWENT A GENERATOR CHANGE OUT TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE FOLLOWING DAY THERE WAS HIGH OUT OF RANGE PACING IMPEDANCES ON BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD MEASURING GREATER THAN 3000 OHMS. ADDITIONALLY, THE SHOCK LEAD IMPEDANCES (SLI) WERE HIGH OUT OF RANGE MEASURING GREATER THAN 200 OHMS. THE HEALTH CARE PROFESSIONAL (HCP) REACHED OUT TO TECHNICAL SERVICES AND DISK ANALYSIS WAS REQUESTED. THE HCP HAD THE PATIENT PERFORM A PATIENT INITIATED INTERROGATION (PII). THE PRESENTING ELECTROGRAM (EGM) AND ALL LEAD MEASUREMENTS WERE WITHIN NORMAL RANGE. THE PLAN IS TO HAVE THE PATIENT PERFORM ANOTHER PII IN THE FOLLOW WEEK TO CONFIRM MEASUREMENTS. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS PATIENT UNDERWENT A GENERATOR CHANGE OUT TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE FOLLOWING DAY THERE WAS HIGH OUT OF RANGE PACING IMPEDANCES ON BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD MEASURING GREATER THAN 3000 OHMS. ADDITIONALLY, THE SHOCK LEAD IMPEDANCES (SLI) WERE HIGH OUT OF RANGE MEASURING GREATER THAN 200 OHMS. THE HEALTH CARE PROFESSIONAL (HCP) REACHED OUT TO TECHNICAL SERVICES AND DISK ANALYSIS WAS REQUESTED. THE HCP HAD THE PATIENT PERFORM A PATIENT INITIATED INTERROGATION (PII). THE PRESENTING ELECTROGRAM (EGM) AND ALL LEAD MEASUREMENTS WERE WITHIN NORMAL RANGE. THE PLAN IS TO HAVE THE PATIENT PERFORM ANOTHER PII IN THE FOLLOW WEEK TO CONFIRM MEASUREMENTS. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1710583 | RESONATE X4 CRT-D | IMPLANTABLE DEVICE | NIK | BOSTON SCIENTIFIC CORPORATION | G447 | 276583 | 00802526589539 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Male |