EBR SYSTEMS, INC.
Report
- Report Number
- 3013596742-2026-00002
- Event Type
- Death
- Date Received
- January 27, 2026
- Date of Event
- January 7, 2026
- Report Date
- April 9, 2026
- Manufacturer
- EBR SYSTEMS, INC.
- Product Code
- SEG
- PMA / PMN Number
- P240028
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE MODEL 3100 BATTERY (S/N (B)(6)) AND MODEL 4100 TRANSMITTER (S/N (B)(6)) WERE NOT RETURNED TO EBR SYSTEMS FOR ANALYSIS AND REMAINED IMPLANTED AT THE TIME OF THE PATIENT'S DEATH; THEREFORE, VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE CLINICAL SITE DID NOT PROVIDE A CAUSE OF DEATH. FOLLOW-UP WITH THE PACEMAKER CLINIC INDICATED THE PATIENT HAD UNDERGONE KNEE REPLACEMENT SURGERY IN DECEMBER, WAS DISCHARGED HOME FOLLOWING THE PROCEDURE, AND SUBSEQUENTLY PASSED AWAY AT AN UNSPECIFIED TIME THEREAFTER. NO ADDITIONAL CLINICAL INFORMATION OR MEDICAL RECORDS WERE AVAILABLE FOR REVIEW. A LOT HISTORY RECORD (LHR) REVIEW FOR THE MODEL 3100 BATTERY (LOT 072318-02) AND MODEL 4100 TRANSMITTER (LOT 082318-02) CONFIRMED THAT ALL MANUFACTURING, TESTING, AND STERILIZATION REQUIREMENTS WERE MET. NO MANUFACTURING DISCREPANCIES OR NONCONFORMANCES WERE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE INVESTIGATION DID NOT IDENTIFY EVIDENCE OF DEVICE MALFUNCTION, PRODUCT PERFORMANCE ISSUES, OR MANUFACTURING NONCONFORMANCE. THE ROOT CAUSE OF THE REPORTED PATIENT DEATH COULD NOT BE DETERMINED, AND THERE IS NO EVIDENCE THAT THE WISE CRT SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.
THE TRANSMITTER REMAINS IMPLANTED AT THIS TIME. THE INVESTIGATION INTO THE PATIENT'S DEATH IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE AND ANY FURTHER RELEVANT DETAILS BECOME AVAILABLE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT'S DEATH HAS BEEN PROVIDED OR IS EXPECTED TO BECOME AVAILABLE. THE INVESTIGATION REMAINS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF FURTHER RELEVANT INFORMATION IS OBTAINED.
EBR SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. EBR HAS MADE REASONABLE EFFORST 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 UNPOPLUATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. EBR WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ADDITIONAL FOLLOW-UP WAS CONDUCTED BY THE EBR REPRESENTATIVE WITH THE PACEMAKER CLINIC NURSE ON (B)(6) 2026, REGARDING THIS PATIENT. THE NURSE REPORTED THAT THE PATIENT UNDERWENT A KNEE REPLACEMENT PROCEDURE IN (B)(6), WAS DISCHARGED HOME, AND SUBSEQUENTLY DIED AT AN UNSPECIFIED LATER DATE. NO FURTHER CLINICAL DETAILS, MEDICAL RECORDS, CAUSE OF DEATH, OR DEVICE-RELATED INFORMATION WERE AVAILABLE OR PROVIDED. AS A RESULT, NO ADDITIONAL INFORMATION IS AVAILABLE TO SUPPORT FURTHER EVALUATION AT THIS TIME.
IT WAS REPORTED THAT A 77-YEAR-OLD MALE WITH ISCHEMIC CARDIOMYOPATHY (EF 32%), ATRIAL FIBRILLATION, AND A PRIOR CRT-D IMPLANT, PASSED AWAY. THE PATIENT RECEIVED A WISE CRT SYSTEM IMPLANT IN (B)(6) 2019. A ROUTINE MODEL 3100 BATTERY REPLACEMENT WAS PERFORMED IN (B)(6) 2025. AT THE TIME OF REPORTING, THE CAUSE AND CIRCUMSTANCES OF DEATH ARE UNKNOWN. THERE HAVE BEEN NO REPORTS OF DEVICE MALFUNCTION OR INFORMATION SUGGESTING A CAUSAL RELATIONSHIP BETWEEN THE WISE CRT SYSTEM AND THE PATIENT'S DEATH. FOLLOW-UP WITH THE CLINICAL SITE IS ONGOING. NO FURTHER INFORMATION HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 292640 | EBR SYSTEMS, INC. | M4100 | SEG | EBR SYSTEMS, INC. | M4100 | 082318-02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Male | Death| O |