BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3830400 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-09569
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 3, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT # VA0FGJJ, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT # VA0FGJJ, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3708660, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 3708660, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SEIZURE ON (B)(6) 2014. HOWEVER, IT WAS NOTED THAT THE HEALTHCARE PROVIDER (HCP) DID NOT KNOW IF IT WAS A SEIZURE, BUT THAT ¿IT PROBABLY WAS A SEIZURE.¿ FOUR DAYS LATER IT WAS REPORTED THAT IT WAS UNKNOWN IF THE EVENT WAS RELATED TO THE DEVICE OR THERAPY. THERE WERE NO DIAGNOSTICS PERFORMED AND NO MALFUNCTIONS WERE OR THE CAUSE OF THE ISSUE DETERMINED. THE PATIENT WOULD BE MONITORED. IT WAS NOTED THAT THE EVENT HAPPENED PRIOR TO TURNING THE THERAPY ON. THE HCP ALSO WROTE THAT DURING MONOPOLAR REVIEW A SIMILAR FEELING COULD BE BROUGHT ON. THE PATIENT WOULD START HAVING ANXIETY AND CRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307158 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Other