WISE CRT SYSTEM
Report
- Report Number
- 3013596742-2025-00036
- Event Type
- Malfunction
- Date Received
- December 12, 2025
- Date of Event
- November 12, 2025
- Report Date
- March 12, 2026
- Manufacturer
- EBR SYSTEMS, INC.
- Product Code
- SEG
- PMA / PMN Number
- P240028
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
NO ADDITIONAL INVESTIGATION CAN BE PERFORMED AS THE MODEL 5100 PROGRAMMER HAS NOT BEEN RETURNED AND WILL NOT BE RETURNED TO EBR SYSTEMS FOR EVALUATION. THEREFORE, FURTHER VISUAL OR FUNCTIONAL ANALYSIS CANNOT BE CONDUCTED.
THE M5100 PROGRAMMER HAS NOT BEEN RETURNED TO EBR FOR EVALUATION. RESULTS AND CONCLUSIONS WILL BE PROVIDED IF AND WHEN THE PROGRAMMER IS RETURNED. EBR SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. EBR HAS MADE REASONABLE EFFORTS TO PROVIDE ASMUCH 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 MODEL M5100 PROGRAMMER HAS NOT YET BEEN RETURNED TO EBR FOR EVALUATION. THE INVESTIGATION REMAINS ONGOING AND HAS NOT YET BEEN COMPLETED. RESULTS AND CONCLUSIONS, INCLUDING ALL RELEVANT INFORMATION, WILL BE PROVIDED IN THE FINAL INVESTIGATION REPORT.
THE MODEL M5100 PROGRAMMER WILL NOT BE RETURNED TO EBR FOR EVALUATION. THE INVESTIGATION REMAINS ONGOING AND HAS NOT YET BEEN COMPLETED. RESULTS AND CONCLUSIONS, INCLUDING ALL RELEVANT INFORMATION, WILL BE PROVIDED IN THE FINAL REPORT.
IT WAS REPORTED THAT THE MODEL 5100 PROGRAMMER TABLET EXPERIENCED DIFFICULTY COMMUNICATING WITH THE IMPLANTED MODEL 4100 TRANSMITTER. SIGNAL STRENGTH WAS REPORTED AS LOW (ONE BAR). COMMUNICATION IMPROVED ONLY WHEN THE TELEMETRY TOWER WAS POSITIONED BETWEEN THE PATIENT'S ARM AND TORSO; HOWEVER, SIGNAL STRENGTH REMAINED LOW DESPITE REPOSITIONING. WHEN AN ENGINEERING LAPTOP WITH A COMMUNICATION MODULE WAS USED FOR A SOFTWARE UPDATE, COMMUNICATION WITH THE IMPLANTED DEVICE WAS STABLE FROM APPROXIMATELY 5-10 FEET AWAY. VISUAL AND FUNCTIONAL EVALUATIONS COULD NOT BE PERFORMED BECAUSE NEITHER THE PROGRAMMER NOR THE IMPLANTED TRANSMITTER WERE RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORDS FOR THE MODEL 4100 TRANSMITTER AND MODEL 5100 PROGRAMMER CONFIRMED THE DEVICES WERE MANUFACTURED, TESTED, AND RELEASED IN ACCORDANCE WITH APPROVED PROCEDURES AND MET ALL ACCEPTANCE CRITERIA. NO MANUFACTURING DISCREPANCIES WERE IDENTIFIED THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. AT THIS TIME, THE ROOT CAUSE HAS NOT BEEN DETERMINED. THE INVESTIGATION REMAINS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
IT WAS REPORTED THAT THERE WAS DIFFICULTY COMMUNICATING WITH THE WISE CRT SYSTEM WHEN USING THE PROGRAMMER. DURING THE FOLLOW-UP WITH THE PATIENT, CONNECTION ISSUES WERE EXPERIENCED UNTIL THE EBR REPRESENTATIVE HAD THE PATIENT POSITION THE TOWER BETWEEN HIS ARM AND TORSO. EVEN WITH THIS ADJUSTMENT, THERE WAS ONLY ONE SMALL BAR OF SIGNAL TO THE DEVICE. NO ADVERSE PATIENT SEQUELAE WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 552247 | WISE CRT SYSTEM | M5100 | SEG | EBR SYSTEMS, INC. | M5100 | P250049 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other |