BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 6169095 · Received December 13, 2016

    Report

    Report Number
    3004209178-2016-26312
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    December 13, 2016
    Report Date
    January 4, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED IT WAS UNKNOWN IF THE CHEST PAIN AND ADMINISTRATION OF ANTICOAGULANTS WAS RELATED TO THE IMPLANT SURGERY OR DEVICE AS WELL AS IT BEING UNKNOWN IF THE CONSUMER HAD ANY UNDERLYING ISSUES WHICH CONTRIBUTED TO THIS. IT WAS ALSO UNKNOWN IF THE MI WAS RELATED TO THE IMPLANT SURGERY OR DEVICE. ACCORDING TO THE CONSUMER¿S NEUROLOGIST THE BRAIN HEMORRHAGE WAS A RESULT OF THE ANTICOAGULATION AND NOT RELATED TO THE DEEP BRAIN STIMULATOR IMPLANT OR THERAPY.

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER (HCP) REPORTED VIA THE MANUFACTURER¿S REPRESENTATIVE (REP) THE CONSUMER HAD THE DEEP BRAIN STIMULATOR (DBS) IM PLANTED ON (B)(6) 2016. ON (B)(6) 2016 THE CONSUMER PRESENTED TO THE HOSPITAL WITH CHEST PAINS WHERE A CARDIOLOGIST ADMINISTERED ANTICOAGULANTS. A CT SCAN WAS PERFORMED ON THE AFTERNOON OF (B)(6) 2016 TO WHICH THE NEUROSURGEON SAID IT WAS CLEAR. AT 4 A.M. ON (B)(6) 2016 THE CONSUMER SUFFERED AN ACUTE MYOCARDIAL INFARCTION AND SUBSEQUENT BRAIN HEMORRHAGE. ACCORDING TO THE NEUROSURGEON THE CONSUMER WAS NOW BRAIN DEAD AND LISTED AS ¿ALIVE WITH INJURY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821792 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R| S