BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXIMO DR

    MDR report key: 2802072 · Received October 23, 2012

    Report

    Report Number
    2647346-2012-01741
    Event Type
    Death
    Date Received
    October 23, 2012
    Date of Event
    March 27, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. THE DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME WAS/WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE.

    Description of Event or Problem · 1

    THE SYSTEM WAS RETURNED WITH NO INFORMATION. A DATABASE SEARCH BY SERIAL NUMBER SHOWED THE PATIENT EXPIRED LESS THAN 1 YEAR AFTER IMPLANT. THE DEATH OCCURRED GREAT THAN 2 YEARS AGO. NO COMPLAINTS, ALLEGATIONS, OR, PREVIOUS CONTACTS, REGARDING THE SYSTEM OR ANY INDIVIDUAL COMPONENTS HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7278

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death