BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXIMO VR

    MDR report key: 2954853 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02487
    Event Type
    Death
    Date Received
    February 11, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM. INTERROGATION OF THE PATIENT'S DEVICE NOTED INTERMITTENT UNDERSENSING AND HIGH THRESHOLDS. IT WAS FURTHER REPORTED THAT MULTIPLE VENTRICULAR EPISODES WERE DETECTED BY THE DEVICE AND NOT CLASSIFIED APPROPRIATELY DUE TO INTERMITTENT UNDERSENSING OF THE VENTRICULAR SIGNAL AND THAT R WAVE TREND SHOWS AN INCREASING VARIABILITY OF R WAVES. THE PATIENT DIED THE FOLLOWING DAY. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58249 MAXIMO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7232CX

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Death| H| R 6949 IMPLANTABLE TACHY LEAD