BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERDIMENSION INREACH BRONCHUS SYSTEM

    MDR report key: 3810046 · Received May 1, 2014

    Report

    Report Number
    3004962788-2014-00028
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    April 4, 2014
    Report Date
    May 1, 2014
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND WILL NOT BE RETURNED. SUPERDIMESION HAS MADE THREE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION AND WAS UNSUCCESSFUL.

    Description of Event or Problem · 1

    THE PATIENT HAD A REACTION TO ANESTHESIA IN WHICH HIS HEART RATE SLOWED DOWN DURING A SUPERDIMENSION PROCEDURE. MEDICATION WAS ADMINISTERED TO BRING HEART RATE BACK UP. PATIENT WAS HOSPITALIZED OVERNIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261896 SUPERDIMENSION INREACH BRONCHUS SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY JAK SUPERDIMENSION INC. 20AAS00161-12

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| O| R