BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WISE CRT SYSTEMS

    MDR report key: 23375929 · Received October 23, 2025

    Report

    Report Number
    3013596742-2025-00023
    Event Type
    Injury
    Date Received
    October 23, 2025
    Date of Event
    October 2, 2025
    Report Date
    December 5, 2025
    Manufacturer
    EBR SYSTEMS, INC.
    Product Code
    SEG
    PMA / PMN Number
    P240028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATTERY (S/N (B)(6) AND TRANSMITTER (S/N (B)(6) INVOLVED IN THIS COMPLAINT WERE RETURNED TO EBR FOR ANALYSIS ON (B)(6) 2025 AND SUBJECTED TO STANDARD VISUAL INSPECTION. THE SURFACES WERE CONSISTENT WITH NORMAL CLINICAL USE, AND NO VISUAL CONDITIONS WERE IDENTIFIED THAT COULD CONTRIBUTE TO, OR EXPLAIN, THE REPORTED SKIN EROSION. IN SUMMARY, ALTHOUGH THE PRODUCTS WERE RETURNED AND INSPECTED, VISUAL INSPECTION CANNOT CONFIRM OR PROVIDE EVIDENCE REGARDING THE REPORTED EROSION EVENT, AS THE ISSUE IS BIOLOGICAL IN NATURE AND UNRELATED TO DEVICE PERFORMANCE.

    Additional Manufacturer Narrative · 0

    THE BATTERY AND TRANSMITTER INVOLVED IN THIS CASE ARE EXPECTED TO BE RETURNED BUT HAVE NOT YET BEEN RECEIVED FOR ANALYSIS. VISUAL INSPECTION, ONCE PERFORMED, IS NOT ANTICIPATED TO REVEAL FINDINGS DIRECTLY RELATED TO THE REPORTED EROSION. DEVICE EROSION IS A RECOGNIZED COMPLICATION IDENTIFIED IN THE WISE CRT IFU (LBL-05300 REV B, SECTION 7) UNDER "ACCESS SITE AND POCKET COMPLICATIONS, INCLUDING SKIN EROSION." POTENTIAL CONTRIBUTING FACTORS INCLUDE SURGICAL POCKET CLOSURE TECHNIQUE, RETAINED SUTURES, OR IMPAIRED WOUND HEALING. THE EVENT IS BIOLOGICAL IN NATURE AND NOT INDICATIVE OF A DEVICE MALFUNCTION. MANUFACTURING TEST DATA CONFIRMED THAT BOTH UNITS MET ALL PERFORMANCE SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE LOT HISTORY RECORDS (LHR) REVEALED NO ANOMALIES. FOR TRANSMITTER LOT 072519-05, STERILITY, ENDOTOXIN, AND BIOLOGICAL INDICATOR TESTING MET ALL ACCEPTANCE CRITERIA. FOR BATTERY LOT 000169 (CIRTEC LOT QS377), NO NONCONFORMANCES WERE IDENTIFIED. BOTH DEVICES WERE MANUFACTURED AND STERILIZED IN COMPLIANCE WITH APPLICABLE STANDARDS. IN CONCLUSION, THE INVESTIGATION DETERMINED THAT THE REPORTED SKIN EROSION WAS A PATIENT-SPECIFIC SURGICAL COMPLICATION RATHER THAN A DEVICE-RELATED OR MANUFACTURING DEFECT. THE DEVICES CONFORMED TO ALL DESIGN AND QUALITY SPECIFICATIONS, AND THE EVENT IS CONSISTENT WITH KNOWN RISKS DESCRIBED IN THE PRODUCT LABELING. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE REQUIRED; HOWEVER, SIMILAR COMPLAINTS WILL CONTINUE TO BE TRACKED AND TRENDED TO MONITOR FOR POTENTIAL EMERGING PATTERNS.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE'S MANUFACTURING AND STERILIZATION RECORDS WAS COMPLETED, INCLUDING LOT HISTORY; THERE WERE NO DEVIATIONS OR NONCONFORMITIES ASSOCIATED WITH THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION, WHICH LIMITED THE ABILITY TO CONDUCT ANY PHYSICAL FUNCTIONAL, AND/OR ROOT CAUSE ANALYSIS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT EXPLANT OF BOTH THE BATTERY AND TRANSMITTER IN (B)(6) DUE TO A POCKET PERFORATION. THE PATIENT WAS ORIGINALLY IMPLANTED IN (B)(6) 2018, WITH THE LAST BATTERY REPLACEMENT IN (B)(6) 2025. ALTHOUGH THE WOUND WAS INITIALLY HEALING WELL, MILD REDNESS LATER PROGRESSED TO EROSION OF THE BATTERY THROUGH THE SKIN. TO PREVENT INFECTION, BOTH THE BATTERY AND TRANSMITTER WERE REMOVED. THE PROCEDURE WAS COMPLETED IN LESS THAN 30 MINUTES WITHOUT COMPLICATIONS, AND BOTH DEVICES WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611908 WISE CRT SYSTEMS MODEL 3100 SEG EBR SYSTEMS, INC. MODEL 3100 000169

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O