BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE

    MDR report key: 1051334 · Received May 15, 2008

    Report

    Report Number
    2124215-2008-99898
    Event Type
    Injury
    Date Received
    May 15, 2008
    Date of Event
    April 18, 2008
    Report Date
    May 15, 2008
    Manufacturer
    *
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. AS OF THIS DATE, THE PRODUCTS HAVE NOT BEEN RETURNED TO BOSTON SCIENTIFIC CRM. IF THESE PRODUCTS SHOULD BE RETURNED, FULL ANALYSIS WILL BE COMPLETED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFO BECOMES AVAILABLE TO OUR CO, THE EVENT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (BSC) CRM RECEIVED INFO FROM A USER FACILITY MEDWATCH REPORT THAT THIS PT EXPERIENCED A SYNCOPAL EPISODE. PER HOSP EVAL, THE PT EXPERIENCED SUSTAINED MONOMORPHIC TACHYCARDIA INDUCED WITH ATRIAL PACING. THE PT WAS TAKEN TO THE OPERATING ROOM AND BOTH THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS WERE FOUND TO BE FRACTURED, VERIFIED FROM AN X-RAY. THE PHYSICIAN WAS UNABLE TO REMOVE THE LEADS ENTIRELY, SO A LASER WAS UTILIZED TO REMOVE BOTH LEADS. EACH LEAD WAS EXTRACTED IN TWO SEPARATE PIECES. THIS PROCEDURE WAS COMPLETED BY USING CONSTANT MONITORING AND TRANSESOPHAGEAL ECHOCARDIOGRAM. NO FURTHER INFO WAS AVAILABLE AS TO WHETHER A NEW PACING SYSTEM WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE IMPLANTABLE LEAD DTB * 4185 *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention