BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAZER II TEMPERATURE ABLATION CATHETER

    MDR report key: 20621984 · Received November 6, 2024

    Report

    Report Number
    2124215-2024-69868
    Event Type
    Injury
    Date Received
    November 6, 2024
    Date of Event
    January 9, 2017
    Report Date
    November 6, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT - THE EXACT EVENT ONSET DATE IS UNKNOWN. THE PROVIDED EVENT DATE OF 09JAN2017 WAS CHOSEN AS THE BEST ESTIMATE BASED ON THE ADMISSION DATE. BLOCKS D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION, DEVICE MANUFACTURE DATES, AND UNIQUE IDENTIFIER (UDI) # ARE UNKNOWN. DEVICE EVALUATION: UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, ANONYMIZED DATA WAS PROVIDED. NO PRODUCTS WERE RETURNED AS PART OF THE REGISTRY. IT CANNOT BE DETERMINED IF THESE EVENTS HAVE BEEN PREVIOUSLY REPORTED OR IF THE DEVICES WERE RETURNED FOR ANALYSIS AS PART OF A PREVIOUSLY REPORTED SPONTANEOUS COMPLAINT. HOWEVER, THE EVENTS REPORTED WERE ANTICIPATED IN NATURE AS DEFINED BY THE "POTENTIAL ADVERSE EVENTS" LIST IN THE FDA-APPROVED INSTRUCTIONS FOR USE (IFU).

    Description of Event or Problem · 0

    PER PMCF PREMIER EP DATA ANALYSIS, IT WAS REPORTED THAT: PROCEDURE ID# (B)(6) REAL WORLD EVIDENCE - RETROSPECTIVE PATIENT BILLING RECORDS REVIEW OF PREMIER HEALTH DATABASE PATIENT ADMISSION DATE: (B)(6) 2017 PATIENT DISCHARGE DATE: (B)(6) 2017. ADVERSE EVENT INCLUDING: SUPRAVENTRICULAR TACHYCARDIA, METABOLIC ENCEPHALOPATHY, OTHER HYPOTENSION, PAIN IN L KN, LOC EDEMA, ADVRS EFF, GLUCOCORTICOIDS, INIT. THE PATIENT WAS DISCHARGED TO ANOTHER REHABILITATION FACILITY. THE FOLLOWING EVENT, BASED ON RETROSPECTIVE REVIEW OF DATA FROM THE PREMIER HEALTH DATABASE, IS BEING REPORTED AS AN EVENT THAT COULD HAVE POTENTIALLY BEEN PREVIOUSLY REPORTED TO BOSTON SCIENTIFIC AND REPORTED AS AN MDR WHEN THE EVENT OCCURRED. BOSTON SCIENTIFIC REPORTS THE EVENTS IN COMPLIANCE TO 21 CFR 803.3. BECAUSE PREMIER HEALTH DATABASE DATA IS DE-IDENTIFIED BEFORE BEING TRANSMITTED TO BOSTON SCIENTIFIC, THERE ARE SIGNIFICANT LIMITATIONS TO BOSTON SCIENTIFIC'S ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY REPORTED TO BOSTON SCIENTIFIC. ADDITIONALLY, EVENT DATE, EVENT OUTCOME, AND INITIAL REPORTER ARE NOT PROVIDED DUE TO THE TERMS OF THE PREMIER HEALTH DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1998592 BLAZER II TEMPERATURE ABLATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Hospitalization