BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPULSE

    MDR report key: 1717068 · Received June 10, 2010

    Report

    Report Number
    2647346-2010-00240
    Event Type
    Injury
    Date Received
    June 10, 2010
    Date of Event
    March 30, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S030
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    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

    THE PATIENT REPORTED FEELING DIZZY/LIGHTHEADED AND BEING ON MEDICATIONS TO HELP SLOW HER HEART BEAT. SHE ALSO STATED THAT SHE FELT "HEART BEAT, THEN A PAUSE, ANOTHER HEART BEAT AND A PAUSE, AND THIS DOESN'T FEEL RIGHT." THE PATIENT STATED THE DEVICE HASN'T BEEN TESTED IN QUITE A WHILE BECAUSE SHE DOESN'T HAVE INSURANCE, BUT SHE WILL BE GOING TO A FREE CLINIC SOON. THE DEVICE REMAINS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENPULSE IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. E1DR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other 5076 IMPLANTABLE PACING LEAD| 5092 IMPLANTABLE PACING LEAD