BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENRHYTHM DR

    MDR report key: 2160425 · Received July 13, 2011

    Report

    Report Number
    2647346-2011-00942
    Event Type
    Death
    Date Received
    July 13, 2011
    Date of Event
    October 20, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    Z-1440-2010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    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 BY A STUDY THAT THE PATIENT WAS DECEASED. THE PATIENT'S DEATH OCCURRED LESS (B)(6) AFTER IMPLANT. FOLLOW UP HAS BEEN INCONCLUSIVE SO FAR. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED. NO COMPLAINTS OR ALLEGATIONS HAVE BEEN MADE AGAINST THE DEVICE SYSTEM OR ANY OF ITS INDIVIDUAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| O