BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

    MDR report key: 11139008 · Received January 8, 2021

    Report

    Report Number
    2522007-2021-00001
    Event Type
    Injury
    Date Received
    January 8, 2021
    Date of Event
    December 9, 2020
    Report Date
    February 15, 2022
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: DRB. PMA/510(K): K170298. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE UNDERGOING A LEAD EXTRACTION PROCEDURE, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. IT APPEARED THAT THE PERICARDIAL EFFUSION OCCURRED WHEN THE LEAD COIL BECAME DETACHED FROM THE MYOCARDIUM. THIS WAS NOT BELIEVED TO BE A DIRECT RESULT OF THE COOK LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET (LR-OFA01) BEING USED AT THE TIME. HOWEVER, THE PHYSICIAN DRAINED THE EFFUSION AND NO SECTION OF THE DEVICE REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39047 LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET DRB COOK VANDERGRIFT INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention