BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS NXT KIT, 71CM, MEDIUM CURL

    MDR report key: 1910789 · Received November 23, 2010

    Report

    Report Number
    3005188751-2010-00118
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ST. JUDE MEDICAL, AF DIV
    Product Code
    DYB
    PMA / PMN Number
    K042623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORDS IS NOT POSSIBLE AS THE LOT NUMBER FOR THE DEVICE IS UNK. THE CAUSE FOR THE REPORTED PERICARDIAL EFFUSION IS UNK. DATE REPORT SUBMITTED TO FDA BY MFR: (B)(4) 2010. DATE INITIAL REPORTER PROVIDED THE INFO TO THE MFR: (B)(4) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER THE PHYSICIAN PERFORMED TRANSSEPTAL PUNCTURE, CHANGES WERE NOTED ON ULTRASOUND TO INDICATE A PERICARDIAL EFFUSION. THE PHYSICIAN ABORTED THE ABLATION PROCEDURE AND A PERICARDIOCENTESIS WAS PERFORMED. THE PT STABILIZED WITH NO FURTHER CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILIS NXT KIT, 71CM, MEDIUM CURL AGILIS NXT DYB ST. JUDE MEDICAL, AF DIV 408315 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention