BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

    MDR report key: 24094478 · Received January 16, 2026

    Report

    Report Number
    2124215-2026-03185
    Event Type
    Injury
    Date Received
    January 16, 2026
    Date of Event
    May 20, 2025
    Report Date
    January 16, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT: ESTIMATED AS 05/20/2025 AS THE PUBLISHED DATE FOR THE ARTICLE IS NOTED AS 20 MAY 2025. D1: BRAND NAME IS BLANK BECAUSE THE DEVICE IS KNOWN TO BE A WATCHMAN LAA CLOSURE DEVICE, BUT THE EXACT BRAND NAME IS UNKNOWN. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. LITERATURE CITATION: DEFRANK, ANNA, BOSCO, MICHAEL, MUNOZ GOMEZ, SIGRIDH, DHALIWAL, AMIT, CEFIDEROCOL-RESISTANT ELIZABETHKINGIA ANOPHELIS BACTEREMIA FOLLOWING WATCHMAN IMPLANTATION: A CASE REPORT AND REVIEW OF THE LITERATURE, CASE REPORTS IN INFECTIOUS DISEASES, 2025, 5221364, 6 PAGES, 2025. HTTPS://DOI.ORG/10.1155/CRDI/5221364.

    Description of Event or Problem · 0

    IT WAS REPORTED ELIZABETHKINGIA ANOPHELIS BACTEREMIA OCCURRED. THIS ARTICLE STATES THAT THE 82-YEAR-OLD PATIENT PRESENTED WITH ACUTE FEVER (103F), NAUSEA, VOMITING, LEUKOCYTOSIS (13.6X10 CELLS/L), AND ELEVATED CRP (126 MG/L), IMMEDIATELY AFTER ELECTIVE CARDIOVERSION FOR ATRIAL FIBRILLATION. BLOOD CULTURES WERE OBTAINED AND EMPIRIC VANCOMYCIN (VAN) AND CEFTRIAXONE (CRO) WERE INITIATED. OTHER COMORBIDITIES INCLUDED CHRONIC KIDNEY DISEASE, PSORIASIS, AND RECENT RIGHT-KNEE PROSTHETIC JOINT INFECTION WITH PSEUDOMONAS AERUGINOSA TREATED WITH SURGICAL WASHOUT AND A 6-MONTH COURSE OF ANTIBIOTICS (ORAL LEVOFLOXACIN [LVX] PLUS MINOCYCLINE). SIX WEEKS PRIOR TO ADMISSION FOR ALL OF THIS, THE PATIENT UNDERWENT ATRIAL ABLATION WITH WATCHMAN IMPLANT. BOTH PAIRS OF BLOOD CULTURES ON TWO CONSECUTIVE DAYS REVEALED E. MENINGOSEPTICA. ANTIMICROBIAL SUSCEPTIBILITY OBTAINED BY AUTOMATED BROTH MICRODILUTION (BMD) SHOWED RESISTANCE TO ALL CEPHALOSPORINS, INCLUDING FDC, AMINO-GLYCOSIDES, CARBAPENEMS, PIPERACILLIN/TAZOBACTAM (TZP), AZTREONAM (ATM), AND TETRACYCLINES. IT WAS SUSCEPTIBLE TO FLUOROQUINOLONES AND COTRIMOXAZOLE (SXT)), AND LVX 750 MG DAILY WAS INITIATED. THE PATIENT HAD NO KNOWN PRIOR EXPOSURE TO FDC. THE ISOLATE WAS SUBMITTED TO A REFERENCE LAB FOR CONFIRMATORY TESTING AND SUBSEQUENT WHOLE GENOME SEQUENCING (WGS). FURTHER WORKUP REVEALED BIBASILAR OPACITIES ON CT CHEST. SPUTUM CULTURE GREW CANDIDA SPECIES, AND BLOOD CULTURES REPEATED 48 HOURS AFTER ANTIBIOTIC TREATMENT REMAINED NEGATIVE. GIVEN THE PROPENSITY OF ELIZABETHKINGIA SPP. TO FORM BIOFILMS, TRANSESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED TO RULE OUT DEVICE-RELATED INFECTION, WHICH DID NOT SHOW ANY VEGETATION. HE WAS TREATED WITH LVX FOR 2 WEEKS. AT 6 WEEK FOLLOW UP, THE PATIENT WAS ASYMPTOMATIC, CHEST X-RAY SHOWED RESOLUTION OF LUNG OPACITIES, TWO SETS OF BLOOD CULTURES WERE NEGATIVE, AND HIS CRP HAD NORMALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155315 SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Other| H