BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXIMO DR

    MDR report key: 1830014 · Received September 10, 2010

    Report

    Report Number
    6000094-2010-01760
    Event Type
    Death
    Date Received
    September 10, 2010
    Date of Event
    October 9, 2009
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT "DIED DUE TO THE AGGRAVATION OF MYOCARDITIS AFTER TOURISM IN (B)(6) IN (B)(6) 2009." THE PATIENT WAS HOSPITALIZED AND EXPERIENCED A VT/VF EPISODE THAT WAS EFFECTIVELY TREATED BY THE DEVICE. "A COLLAPSE OF PUPIL DILATION EYE WITH A WEAK REACTION TO LIGHT WAS DIAGNOSED." RESUSCITATION WAS ATTEMPTED, BUT WAS UNSUCCESSFUL. AN AUTOPSY WAS PERFORMED AND NOTED FRESH FOCI OF MYOCARDITIS OF THE HEART. THERE IS NO ALLEGATION BY A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. 7278 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death