BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4871395 · Received June 26, 2015

    Report

    Report Number
    3004209178-2015-12323
    Event Type
    Injury
    Date Received
    June 26, 2015
    Report Date
    June 4, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3389S-40, LOT# VA05216, IMPLANTED: 2015 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3389S-40, LOT# VA05216, IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THREE EPILEPTIC OR TRANSIENT ISCHEMIC ATTACK (TIA) EPISODES IN THE LAST TWO MONTHS SINCE THE INTERSTIM DEVICE WAS ON. THE PATIENT REFERRED TO TIA AS ¿MINI STROKES¿. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. INFORMATION UNRELATED TO THIS EVENT WAS INCLUDED IN A SEVERAL SEPARATE PES. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414944 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Other