BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIVA

    MDR report key: 5669495 · Received May 20, 2016

    Report

    Report Number
    2649622-2016-05582
    Event Type
    Death
    Date Received
    May 20, 2016
    Date of Event
    May 3, 2016
    Report Date
    May 20, 2016
    Manufacturer
    MPRI
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX, DATE OF BIRTH.

    Description of Event or Problem · 1

    THE HEALTHCARE PROVIDER (HCP) REPORTED VIA THE MANUFACTURER'S REPRESENTATIVE (REP) THE CONSUMER WHO WAS IMPLANTED ON (B)(6) 2016 HAD AN INTRACRANIAL HEMORRHAGE ON (B)(6) AND THE DEVICE WAS EXPLANTED THAT SAME DAY. THE HCP WAS UNAWARE OF ANY FACTORS THAT COULD HAVE CAUSED THIS OR ANY DIAGNOSTICS OR TROUBLESHOOTING THAT WERE PERFORMED. THE DEVICE WAS GOING TO BE REPLACED IN THE FUTURE BUT THE CONSUMER DIED ON (B)(6) AS A RESULT OF THE HEMORRHAGIC STROKE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REPORTED THE INTRACRANIAL HEMORRHAGE WAS RELATED TO THE LEAD PLACEMENT. THE CONSUMER WAS IN CRITICAL CARE AND WASN'T ABLE TO BE WEANED OFF OF THE VENTILATOR AND THE FAMILY DECIDED TO DISCONTINUE CARE. THE CONSUMER DIED IN CRITICAL CARE DUE TO THE AFTER EFFECTS OF THE STROKE. AN AUTOPSY WAS DONE, BUT THEY DIDN'T HAVE THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324366 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MPRI 3387S-40 VA14W3V

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| H| R