BEUDAMED
    FDA Adverse Event Death Summary report: N

    INNOVA 2121-IQ

    MDR report key: 3819934 · Received May 14, 2014

    Report

    Report Number
    9611343-2014-00066
    Event Type
    Death
    Date Received
    May 14, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    JAA
    PMA / PMN Number
    K060259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT DIED DURING PACEMAKER EXTRACTION PROCEDURE WITH AN INNOVA (B)(4) VASCULAR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287882 INNOVA 2121-IQ INTERVENTIONAL FLUOROSCOPIC X-RAY JAA GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death