BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2811101 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01862
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 24, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IN BRADYCARDIA AND THERE WAS NO CAPTURE. THE EXTERNAL PULSE GENERATOR WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention