BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3193667 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-10979
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 7, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389S-40, LOT# VA05CBS, IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 3389S-40, LOT# VA07K5N, 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: PRODUCT ID 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED CONFUSION, INCREASED IRRITABILITY, URINARY INCONTINENCE, AND HALLUCINATIONS. THE PATIENT WAS ALSO ARGUMENTATIVE. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION. THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013. THE EVENT WAS CONSIDERED TO BE POST OPERATIVE SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294796 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization