WISE CRT SYSTEM
Report
- Report Number
- 3013596742-2025-00037
- Event Type
- Malfunction
- Date Received
- November 25, 2025
- Date of Event
- November 21, 2025
- Report Date
- December 22, 2025
- Manufacturer
- EBR SYSTEMS, INC
- Product Code
- SEG
- PMA / PMN Number
- P240028
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
EBR SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. EBR HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, EBR, OR ITS EMPLOYEES THAT THE DEVICE, EBR, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. EBR WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
THE BATTERY AND TRANSMITTER WERE NOT RETURNED FOR ANALYSIS, PREVENTING FUNCTIONAL TESTING, THOUGH REVIEW OF PROGRAMMER LOGS INDICATED THAT AS OF 17-NOV-2025, BATTERY (B)(6) HAD APPROXIMATELY 8% REMAINING ENERGY. UNDER NORMAL CONDITIONS, EVEN AT END-OF-SERVICE, THE WISE TRANSMITTER IS EXPECTED TO MAINTAIN BASIC RADIO COMMUNICATION, MAKING THE COMPLETE LOSS OF COMMUNICATION INCONSISTENT WITH NORMAL EOS BEHAVIOR. WHILE THE LAST BATTERY VOLTAGE APPEARED NORMAL, IT WAS MEASURED EIGHT MONTHS PRIOR, AND RAPID PROGRESSION OF CURRENT-LEAKAGE ISSUES ASSOCIATED WITH FSN 20-001 KYROFLEX FEEDTHROUGH MECHANISMS IS POSSIBLE. LOT HISTORY RECORD REVIEW CONFIRMED THAT ALL MANUFACTURING, INSPECTION, LABELING, TRACEABILITY, AND STERILIZATION PROCEDURES FOR THE TRANSMITTER AND BATTERY WERE COMPLETE AND COMPLIANT, WITH NO NONCONFORMANCES IDENTIFIED. THE COMPLAINT IS CONFIRMED FOR LOSS OF WISE POWER SYSTEM. THE ASSOCIATED LOSS OF BIV PACING, REFLECTED AS RV-ONLY PACING ON ECG, IS AN EXPECTED CONSEQUENCE WHEN THE WISE SYSTEM IS NO LONGER POWERED. AVAILABLE INFORMATION INDICATES THAT THE BATTERY WAS NEAR DEPLETION PRIOR TO THE EVENT, AND THE SUDDEN INABILITY TO ESTABLISH COMMUNICATION IS MOST CONSISTENT WITH COMPLETE BATTERY DEPLETION. BATTERY DEPLETION MAY HAVE BEEN ACCELERATED BY KNOWN KYROFLEX FEEDTHROUGH-RELATED CURRENT LEAKAGE. THE EXACT MECHANISM CANNOT BE CONFIRMED WITHOUT RETURNED HARDWARE.
IT WAS REPORTED THAT THE PATIENT WAS SEEN BY THEIR TREATING PHYSICIAN FOR INTRAVENOUS DIURETICS DUE TO FLUID RETENTION. THE PATIENT HAD BEEN HOSPITALISED IN LATE (B)(6) FOR WORSENING HEART FAILURE AND WAS ONLY RECENTLY DISCHARGED, WHICH PREVENTED THE PLANNED WISE SYSTEM FOLLOW-UP IN (B)(6). DURING THE (B)(6) VISIT, THE PRESENTING ECG SHOWED RV-ONLY PACING. WHEN THE PHYSICIAN ATTEMPTED TO INTERROGATE THE WISE CRT SYSTEM, COMMUNICATION COULD NOT BE ESTABLISHED. THE EBR REPRESENTATIVE WAS NOT PRESENT DURING THE VISIT BUT WAS INFORMED THAT NO WAND-BASED OR ACTIVE COMMUNICATION COULD BE ACHIEVED WITH EITHER THE WISE SYSTEM OR THE CO-IMPLANTED DEVICE DURING INTERROGATION ATTEMPTS. NO ADVERSE PATIENT SEQUELAE WERE REPORTED.
THE PATIENT'S DISCHARGE LETTER WAS RECEIVED, INDICATING SHE WAS DISCHARGED ON (B)(6) 2025 WITH HEART FAILURE DUE TO DILATED CARDIOMYOPATHY AND PERMANENT ATRIAL FIBRILLATION, ALONG WITH CHRONIC KIDNEY DISEASE, TYPE 2 DIABETES, AND CHRONIC SKIN PROBLEMS ON THE LEGS. THE PATIENT ALSO HAD A HISTORY OF INFECTIONS, PERIPHERAL ARTERY DISEASE WITH PREVIOUS AORTIC SURGERY, AND PULMONARY NODULES. THE PATIENT SUBSEQUENTLY PASSED AWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2672631 | WISE CRT SYSTEM | M4100 | SEG | EBR SYSTEMS, INC | M4100 | 102318-04 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Female | Death |