BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREATBATCH MEDICAL STEERABLE SHEATH

    MDR report key: 5036132 · Received August 27, 2015

    Report

    Report Number
    2183787-2015-00094
    Event Type
    Injury
    Date Received
    August 27, 2015
    Date of Event
    July 1, 2015
    Report Date
    October 2, 2015
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K061119
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED MODEL NUMBER OF DEVICE INVOLVED WITH EVENT FROM 10876-001 (8 FR) TO 10876-002 (9 FR). ALL OTHER REPORTED INFORMATION FROM ORIGINAL MDR 2183787-2015-00094 REMAINS UNCHANGED.

    Description of Event or Problem · 1

    ON (B)(4), A THROMBUS IN THE LEFT ATRIUM HAD BEEN REPORTED BY THE CENTER. AS THE RF ABLATION PROCEDURE HAD BEEN PERFORMED ON (B)(6), THE SPONSOR IS ASSESSING THIS EVENT TO BE POSSIBLY RELATED TO THE PROCEDURE, ALSO BECAUSE THE PATIENT HAS NO MEDICAL HISTORY OF THROMBO-EMBOLIC EVENTS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566951 GREATBATCH MEDICAL STEERABLE SHEATH INTRODUCER, CATHETER DYB GREATBATCH MEDICAL 10876-002 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention