BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIVA

    MDR report key: 3922142 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12698
    Event Type
    Death
    Date Received
    July 9, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3387S-40, LOT# VA0405A, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# VA03X0T, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DEATH WAS CONSIDERED TO BE ¿ABSOLUTELY NOT¿ RELATED TO THE DEVICE OR THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT COMMITTED SUICIDE ON (B)(6) 2014 AND LEFT NO NOTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401397 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Death